United States cosmetic ingredient regulations

D&C Red No. 6

D&C Red No. 6. (a) Identity and specifications. The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of § 74.1306 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982]

Conditions: D&C Red No. 6. (a) Identity and specifications. The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of § 74.1306 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982]

Source:21 CFR 74.2306 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 6

D&C Red No. 6. (a) The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of § 74.1306 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982]

Conditions: D&C Red No. 6. (a) The color additive D&C Red No. 6 shall conform in identity and specifications to the requirements of § 74.1306 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 6 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982]

Source:21 CFR 82.1306 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 7

D&C Red No. 7 (a) Identity and specifications. The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of § 74.1307 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 7 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982]

Conditions: D&C Red No. 7 (a) Identity and specifications. The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of § 74.1307 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 7 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Red No. 7 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 57688, Dec. 28, 1982]

Source:21 CFR 74.2307 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 7

D&C Red No. 7. (a) The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of § 74.1307 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982]

Conditions: D&C Red No. 7. (a) The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of § 74.1307 (a)(1) and (b) of this chapter. (b) The color additive D&C Red No. 7 may be safely used for coloring drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7 does not exceed 5 milligrams per daily dose of the drug. [47 FR 57691, Dec. 28, 1982]

Source:21 CFR 82.1307 · version 2026-08-27 · source checked 2026-08-30

D&C Violet No. 2

D&C Violet No. 2. (a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Violet No. 2. (a) Identity and specifications. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Violet No. 2 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2602 · version 2026-08-27 · source checked 2026-08-30

D&C Violet No. 2

D&C Violet No. 2. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b) of this chapter.

Conditions: D&C Violet No. 2. The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § 74.1602(a)(1) and (b) of this chapter.

Source:21 CFR 82.1602 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 10

D&C Yellow No. 10. (a) Identity and specifications. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Yellow No. 10 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter. [48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]

Conditions: D&C Yellow No. 10. (a) Identity and specifications. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Yellow No. 10 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 10 shall be certified in accordance with regulations in part 80 of this chapter. [48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984]

Source:21 CFR 74.2710 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 10

D&C Yellow No. 10. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b) of this chapter. [48 FR 39220, Aug. 30, 1983]

Conditions: D&C Yellow No. 10. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of § 74.1710(a)(1) and (b) of this chapter. [48 FR 39220, Aug. 30, 1983]

Source:21 CFR 82.1710 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 11

D&C Yellow No. 11. (a) Identity and specifications. The color additive D&C Yellow No. 11 shall conform in identity and specifications to the requirements of § 74.1711(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 11 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Yellow No. 11. (a) Identity and specifications. The color additive D&C Yellow No. 11 shall conform in identity and specifications to the requirements of § 74.1711(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 11 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2711 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 7

D&C Yellow No. 7. (a) Identity and specifications. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Yellow No. 7. (a) Identity and specifications. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 7 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 7 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2707 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 7

D&C Yellow No. 7. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics.

Conditions: D&C Yellow No. 7. The color additive D&C Yellow No. 7 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 7 is restricted to use in externally applied drugs and cosmetics.

Source:21 CFR 82.1707 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 8

D&C Yellow No. 8. (a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1708(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 8 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Yellow No. 8. (a) Identity and specifications. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1708(a)(1) and (b). (b) Uses and restrictions. D&C Yellow No. 8 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of D&C Yellow No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2708 · version 2026-08-27 · source checked 2026-08-30

D&C Yellow No. 8

D&C Yellow No. 8. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 8 is restricted to use in externally applied drugs and cosmetics.

Conditions: D&C Yellow No. 8. The color additive D&C Yellow No. 8 shall conform in identity and specifications to the requirements of § 74.1707(a)(1) and (b) of this chapter. D&C Yellow No. 8 is restricted to use in externally applied drugs and cosmetics.

Source:21 CFR 82.1708 · version 2026-08-27 · source checked 2026-08-30

Dihydroxyacetone

CAS 96-26-4 · EC 202-494-5

Dihydroxyacetone. (a) Identity and specifications. The color additive dihydroxyacetone shall conform in identity and specifications to the requirements of § 73.1150 (a)(1) and (b). (b) Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied cosmetics intended solely or in part to impart a color to the human body. (c) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

Conditions: Dihydroxyacetone. (a) Identity and specifications. The color additive dihydroxyacetone shall conform in identity and specifications to the requirements of § 73.1150 (a)(1) and (b). (b) Uses and restrictions. Dihydroxyacetone may be safely used in amounts consistent with good manufacturing practice in externally applied cosmetics intended solely or in part to impart a color to the human body. (c) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

Source:21 CFR 73.2150 · version 2026-08-27 · source checked 2026-08-30

Disodium EDTA-copper

CAS 14025-15-1 · EC 237-864-5

Disodium EDTA-copper. (a) Identity. The color additive disodium EDTA-copper is disodium [[ N,N′- 1,2- ethanediylbis[ N - (carboxymethyl) glycinato]] (4-)- N,N′,O,O′,O N , O N ′] cuprate (2-). (b) Specifications. Disodium EDTA-copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Total copper, not less than 13.5 percent. Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent. Free copper, not more than 100 parts per million. Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics. (d) Labeling requirements. The labeling of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

Conditions: Disodium EDTA-copper. (a) Identity. The color additive disodium EDTA-copper is disodium [[ N,N′- 1,2- ethanediylbis[ N - (carboxymethyl) glycinato]] (4-)- N,N′,O,O′,O N , O N ′] cuprate (2-). (b) Specifications. Disodium EDTA-copper shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Total copper, not less than 13.5 percent. Total (ethylene-dinitrilo) tetracetic acid, not less than 62.5 percent. Free copper, not more than 100 parts per million. Free disodium salt of (ethylene-dinitrilo) tetraacetic acid, not more than 1.0 percent. Moisture, not more than 15 percent. Water insoluble matter, not more than 0.2 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. Disodium EDTA-copper may be safely used in amounts consistent with good manufacturing practices in the coloring of shampoos which are cosmetics. (d) Labeling requirements. The labeling of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

Source:21 CFR 73.2120 · version 2026-08-27 · source checked 2026-08-30

FD&C Blue No. 1

FD&C Blue No. 1. (a) Identity. The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[ p -[ethyl( m -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( m -sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[ p -[ethyl( p -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( p -sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[ p -[ethyl( o -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( o -sulfobenzyl)ammonium hydroxide inner salt. Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed condensation of one mole of sodium 2-formylbenzenesulfonate with two moles from a mixture consisting principally of 3-[(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid, or with dichromate and acid, or with manganese dioxide and acid to form the dye. The intermediate sodium 2-formylbenzenesulfonate is prepared from 2-chlorobenzaldehyde and sodium sulfite. (b) Specifications. (1) The color additive FD&C Blue No. 1 shall conform in specifications to the requirements of § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994]

Conditions: FD&C Blue No. 1. (a) Identity. The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl[4-[ p -[ethyl( m -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( m -sulfobenzyl)ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl[4-[ p -[ethyl( p -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( p -sulfobenzyl)ammonium hydroxide inner salt and ethyl[4-[ p -[ethyl( o -sulfobenzyl)amino]-α-( o -sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene]( o -sulfobenzyl)ammonium hydroxide inner salt. Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed condensation of one mole of sodium 2-formylbenzenesulfonate with two moles from a mixture consisting principally of 3-[(ethylphenylamino)methyl] benzenesulfonic acid, and smaller amounts of 4-[(ethylphenylamino)methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid, or with dichromate and acid, or with manganese dioxide and acid to form the dye. The intermediate sodium 2-formylbenzenesulfonate is prepared from 2-chlorobenzaldehyde and sodium sulfite. (b) Specifications. (1) The color additive FD&C Blue No. 1 shall conform in specifications to the requirements of § 74.101(b). (2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42565, Sept. 28, 1982, as amended at 58 FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, 1994]

Source:21 CFR 74.2101 · version 2026-08-27 · source checked 2026-08-30

FD&C Green No. 3

FD&C Green No. 3. (a) Identity and specifications. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of § 74.203(a)(1) and (b). (b) Uses and restrictions. The color additive FD&C Green No. 3 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 52144, Nov. 19, 1982]

Conditions: FD&C Green No. 3. (a) Identity and specifications. The color additive FD&C Green No. 3 shall conform in identity and specifications to the requirements of § 74.203(a)(1) and (b). (b) Uses and restrictions. The color additive FD&C Green No. 3 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Green No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 52144, Nov. 19, 1982]

Source:21 CFR 74.2203 · version 2026-08-27 · source checked 2026-08-30

FD&C Red No. 4

FD&C Red No. 4. (a) Identity and specifications. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of § 74.1304(a)(1) and (b). (b) Uses and restrictions. FD&C Red No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 4 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: FD&C Red No. 4. (a) Identity and specifications. The color additive FD&C Red No. 4 shall conform in identity and specifications to the requirements of § 74.1304(a)(1) and (b). (b) Uses and restrictions. FD&C Red No. 4 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 4 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2304 · version 2026-08-27 · source checked 2026-08-30

FD&C Red No. 40

FD&C Red No. 40. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b) of this chapter. (2) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter. (b) Uses and restrictions. FD&C Red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are subject to the following restrictions: (1) The color additive may be used in amounts consistent with current good manufacturing practice. (2) The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 40 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]

Conditions: FD&C Red No. 40. (a) Identity and specifications. (1) The color additive FD&C Red No. 40 shall conform in identity and specifications to the requirements of § 74.340(a)(1) and (b) of this chapter. (2) The listing of this color additive includes lakes prepared as described in §§ 82.51 and 82.1051 of this chapter, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by § 82.51 or § 82.1051 of this chapter. (b) Uses and restrictions. FD&C Red No. 40 may be safely used in coloring cosmetics generally, except that only FD&C Red No. 40 and FD&C Red No. 40 Aluminum Lake may be safely used in coloring cosmetics intended for use in the area of the eye. These uses are subject to the following restrictions: (1) The color additive may be used in amounts consistent with current good manufacturing practice. (2) The color additive shall not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives or any other condition that may affect their integrity. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Red No. 40 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]

Source:21 CFR 74.2340 · version 2026-08-27 · source checked 2026-08-30

FD&C Yellow No. 5

CAS 1934-21-0

FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]

Conditions: FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]

Source:21 CFR 74.2705 · version 2026-08-27 · source checked 2026-08-30

FD&C Yellow No. 6

FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706 (a)(1) and (b). (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [51 FR 41782, Nov. 19, 1986]

Conditions: FD&C Yellow No. 6. (a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of § 74.706 (a)(1) and (b). (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring cosmetics generally in amounts consistent with current good manufacturing practice. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [51 FR 41782, Nov. 19, 1986]

Source:21 CFR 74.2706 · version 2026-08-27 · source checked 2026-08-30

Ferric ammonium ferrocyanide

Ferric ammonium ferrocyanide. (a) Identity and specifications. The color additive ferric ammonium ferrocyanide shall conform in identify and specifications to the requirements of § 73.1298 (a)(1) and (b). (b) Uses and restrictions. Ferric ammonium ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978]

Conditions: Ferric ammonium ferrocyanide. (a) Identity and specifications. The color additive ferric ammonium ferrocyanide shall conform in identify and specifications to the requirements of § 73.1298 (a)(1) and (b). (b) Uses and restrictions. Ferric ammonium ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 38562, July 29, 1977, as amended at 43 FR 6939, Feb. 17, 1978]

Source:21 CFR 73.2298 · version 2026-08-27 · source checked 2026-08-30

Ferric ferrocyanide

Ferric ferrocyanide. (a) Identity and specifications. The color additive ferric ferrocyanide shall conform in identity and specifications to the requirements of § 73.1299(a)(1) and (b). (b) Uses and restrictions. Ferric ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification under section 721(c) of the act. [43 FR 54236, Nov. 21, 1978]

Conditions: Ferric ferrocyanide. (a) Identity and specifications. The color additive ferric ferrocyanide shall conform in identity and specifications to the requirements of § 73.1299(a)(1) and (b). (b) Uses and restrictions. Ferric ferrocyanide is safe for use in coloring externally applied cosmetics, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification under section 721(c) of the act. [43 FR 54236, Nov. 21, 1978]

Source:21 CFR 73.2299 · version 2026-08-27 · source checked 2026-08-30

General

General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.

Conditions: General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use only in drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.

Source:21 CFR 82.1050 · version 2026-08-27 · source checked 2026-08-30

General

General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.

Conditions: General. A batch of a straight color listed in this subpart may be certified, in accordance with the provisions of this part, for use in externally applied drugs and cosmetics, if such batch conforms to the requirements of § 82.5 and to the specifications set forth in this subpart for such color.

Source:21 CFR 82.2050 · version 2026-08-27 · source checked 2026-08-30

Guaiazulene

CAS 489-84-9 · EC 207-701-2

Guaiazulene. (a) Identity. (1) The color additive, guaiazulene, is principally 1,4-dimethyl-7-isopropyl-azulene. (2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent: Polyethylene glycol-40 castor oil (PEG-40 castor oil). Saponification No., 60 to 70. Hydroxyl No., 63 to 78. Acid No., 2. Specific gravity, 1.05 to 1.07. (b) Specifications. Guaiazulene shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice. Melting point, 30.5 °C to 31.5 °C. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 99 percent. (c) Uses and restrictions. Guaiazulene may be safely used in externally applied cosmetics in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Conditions: Guaiazulene. (a) Identity. (1) The color additive, guaiazulene, is principally 1,4-dimethyl-7-isopropyl-azulene. (2) Color additive mixtures of guaiazulene for cosmetic use may contain the following diluent: Polyethylene glycol-40 castor oil (PEG-40 castor oil). Saponification No., 60 to 70. Hydroxyl No., 63 to 78. Acid No., 2. Specific gravity, 1.05 to 1.07. (b) Specifications. Guaiazulene shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such other impurities may be avoided by good manufacturing practice. Melting point, 30.5 °C to 31.5 °C. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 99 percent. (c) Uses and restrictions. Guaiazulene may be safely used in externally applied cosmetics in amounts consistent with good manufacturing practice. (d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Source:21 CFR 73.2180 · version 2026-08-27 · source checked 2026-08-30

Guanine

CAS 73-40-5 · EC 200-799-8

Guanine. (a) Identity and specifications. (1) The color additive guanine shall conform in identity and specifications to the requirements of § 73.1329 (a)(1) and (b). (2) Color additive mixtures of guanine may contain the following diluents: (i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1); (ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Use and restrictions. The color additive guanine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37537, July 22, 1977]

Conditions: Guanine. (a) Identity and specifications. (1) The color additive guanine shall conform in identity and specifications to the requirements of § 73.1329 (a)(1) and (b). (2) Color additive mixtures of guanine may contain the following diluents: (i) For coloring cosmetics generally, only those diluents listed under § 73.1001(a)(1); (ii) For coloring externally applied cosmetics, only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Use and restrictions. The color additive guanine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37537, July 22, 1977]

Source:21 CFR 73.2329 · version 2026-08-27 · source checked 2026-08-30

Henna

CAS 83-72-7 / 84988-66-9 · EC 201-496-3 / 284-854-1

Henna. (a) Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. ( Lawsonia inermis L.). It may be identified by its characteristic odor and by characteristic plant histology. (b) Specifications. Henna shall conform to the following specifications: It shall not contain more than 10 percent of plant material from Lawsonia alba Lam. ( Lawsonia inermis L.) other than the leaf and petiole, and shall be free from admixture with material from any other species of plant. Moisture, not more than 10 percent. Total ash, not more than 15 percent. Acid-insoluble ash, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye. (d) Labeling. The label for henna shall bear the information required by § 70.25 of this chapter and the following statements or their equivalent: “Do not use in the area of the eye.” “Do not use on cut or abraded scalp.” (e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Conditions: Henna. (a) Identity. The color additive henna is the dried leaf and petiole of Lawsonia alba Lam. ( Lawsonia inermis L.). It may be identified by its characteristic odor and by characteristic plant histology. (b) Specifications. Henna shall conform to the following specifications: It shall not contain more than 10 percent of plant material from Lawsonia alba Lam. ( Lawsonia inermis L.) other than the leaf and petiole, and shall be free from admixture with material from any other species of plant. Moisture, not more than 10 percent. Total ash, not more than 15 percent. Acid-insoluble ash, not more than 5 percent. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. (c) Uses and restrictions. The color additive henna may be safely used for coloring hair only. It may not be used for coloring the eyelashes or eyebrows, or generally in the area of the eye. (d) Labeling. The label for henna shall bear the information required by § 70.25 of this chapter and the following statements or their equivalent: “Do not use in the area of the eye.” “Do not use on cut or abraded scalp.” (e) Exemption from certification. Certification of this color additive for the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Source:21 CFR 73.2190 · version 2026-08-27 · source checked 2026-08-30

Iron oxides

Iron oxides. (a) Identity. The color additives iron oxides consist of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances. (b) Specifications. Iron oxides shall conform to the following specifications, all on an “as is” basis: Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. Iron oxides are safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Conditions: Iron oxides. (a) Identity. The color additives iron oxides consist of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances. (b) Specifications. Iron oxides shall conform to the following specifications, all on an “as is” basis: Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 10 parts per million. Mercury (as Hg), not more than 3 parts per million. (c) Uses and restrictions. Iron oxides are safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Source:21 CFR 73.2250 · version 2026-08-27 · source checked 2026-08-30

Lakes (D&C)

Lakes (D&C). (a)(1) General. Any lake, other than those listed in subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or any combination of two or more of these, (i) one of the straight colors (except lakes) listed in subpart B or hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium; or (ii) a salt prepared from one of the straight colors (except lakes) listed in subpart B, or hereinbefore listed in this subpart, by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium. (2) Specifications. Ether extracts, not more than 0.5 percent. Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2 percent. (b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows: (1) The listed name of the color from which the lake is prepared, except that if such name contains the symbol “FD&C” such symbol shall be changed to “D&C”; (2) The name of the basic radical combined in such color; and (3) The word “Lake.” (For example, the name of a lake prepared by extending the color D&C Red No. 9 upon a substratum is “D&C Red No. 9—Barium Lake”, and a lake prepared by extending the aluminum salt prepared from FD&C Green No. 1 upon a substratum other than alumina is “D&C Green No. 1—Aluminum Lake”.)

Conditions: Lakes (D&C). (a)(1) General. Any lake, other than those listed in subpart B, made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or any combination of two or more of these, (i) one of the straight colors (except lakes) listed in subpart B or hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium; or (ii) a salt prepared from one of the straight colors (except lakes) listed in subpart B, or hereinbefore listed in this subpart, by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium. (2) Specifications. Ether extracts, not more than 0.5 percent. Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2 percent. (b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows: (1) The listed name of the color from which the lake is prepared, except that if such name contains the symbol “FD&C” such symbol shall be changed to “D&C”; (2) The name of the basic radical combined in such color; and (3) The word “Lake.” (For example, the name of a lake prepared by extending the color D&C Red No. 9 upon a substratum is “D&C Red No. 9—Barium Lake”, and a lake prepared by extending the aluminum salt prepared from FD&C Green No. 1 upon a substratum other than alumina is “D&C Green No. 1—Aluminum Lake”.)

Source:21 CFR 82.1051 · version 2026-08-27 · source checked 2026-08-30

Lakes (Ext. D&C)

Lakes (Ext. D&C). (a)(1) General. Any lake made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or on any combination of two or more of these (i) one of the straight colors hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, barium, or calcium; or (ii) a salt prepared from one of the straight colors hereinbefore listed in this subpart by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium. (2) Specifications. Ether extracts, not more than 0.5 percent. Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2 percent. (b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows: (1) The listed name of the color from which the lake is prepared; (2) The name of the basic radical combined in such color; and (3) The word “Lake.” (For example, the name of a lake prepared by extending the color Ext. D&C Yellow No. 2 upon a substratum is “Ext. D&C Yellow No. 2—Calcium Lake,” and a lake prepared by extending the barium salt prepared from Ext. D&C Red No. 2 upon the substratum is “Ext. D&C Red No. 2—Barium Lake.”)

Conditions: Lakes (Ext. D&C). (a)(1) General. Any lake made by extending on a substratum of alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate, or on any combination of two or more of these (i) one of the straight colors hereinbefore listed in this subpart, which color is a salt in which is combined the basic radical sodium, potassium, barium, or calcium; or (ii) a salt prepared from one of the straight colors hereinbefore listed in this subpart by combining such color with the basic radical sodium, potassium, aluminum, barium, calcium, strontium, or zirconium. (2) Specifications. Ether extracts, not more than 0.5 percent. Soluble chlorides and sulfates (as sodium salts), not more than 3.0 percent. Intermediates, not more than 0.2 percent. (b) Each lake made as prescribed in paragraph (a) of this section shall be considered to be a straight color and to be listed therein under the name which is formed as follows: (1) The listed name of the color from which the lake is prepared; (2) The name of the basic radical combined in such color; and (3) The word “Lake.” (For example, the name of a lake prepared by extending the color Ext. D&C Yellow No. 2 upon a substratum is “Ext. D&C Yellow No. 2—Calcium Lake,” and a lake prepared by extending the barium salt prepared from Ext. D&C Red No. 2 upon the substratum is “Ext. D&C Red No. 2—Barium Lake.”)

Source:21 CFR 82.2051 · version 2026-08-27 · source checked 2026-08-30

Luminescent zinc sulfide

Luminescent zinc sulfide. (a) Identity. The color additive luminescent zinc sulfide is zinc sulfide containing a copper activator. Following excitation by daylight or a suitable artificial light, luminescent zinc sulfide produces a yellow-green phosphorescence with a maximum at 530 nanometers. (b) Specifications. Luminescent zinc sulfide shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Zinc sulfide, not less than 99.8 percent. Copper, 100 ± 5 parts per million. Lead, not more than 20 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Cadmium, not more than 15 parts per million. (c) Uses and restrictions. The color additive luminescent zinc sulfide may be safely used for coloring externally applied facial makeup preparations and nail polish included under § 720.4(c)(7)(ix) and (c)(8)(v) of this chapter, respectively, to the following restrictions: (1) The amount of luminescent zinc sulfide in facial makeup preparations shall not exceed 10 percent by weight of the final product. (2) Facial makeup preparations containing luminescent zinc sulfide are intended for use only on limited, infrequent occasions, e.g., Halloween, and not for regular or daily use. (d) Labeling requirements. (1) The label of the color additive and any mixtures prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The label of a facial makeup preparation containing the color additive shall bear, in addition to other information required by the law, the following statement conspicuously displayed: Do not use in the area of the eye. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000]

Conditions: Luminescent zinc sulfide. (a) Identity. The color additive luminescent zinc sulfide is zinc sulfide containing a copper activator. Following excitation by daylight or a suitable artificial light, luminescent zinc sulfide produces a yellow-green phosphorescence with a maximum at 530 nanometers. (b) Specifications. Luminescent zinc sulfide shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: Zinc sulfide, not less than 99.8 percent. Copper, 100 ± 5 parts per million. Lead, not more than 20 parts per million. Arsenic, not more than 3 parts per million. Mercury, not more than 1 part per million. Cadmium, not more than 15 parts per million. (c) Uses and restrictions. The color additive luminescent zinc sulfide may be safely used for coloring externally applied facial makeup preparations and nail polish included under § 720.4(c)(7)(ix) and (c)(8)(v) of this chapter, respectively, to the following restrictions: (1) The amount of luminescent zinc sulfide in facial makeup preparations shall not exceed 10 percent by weight of the final product. (2) Facial makeup preparations containing luminescent zinc sulfide are intended for use only on limited, infrequent occasions, e.g., Halloween, and not for regular or daily use. (d) Labeling requirements. (1) The label of the color additive and any mixtures prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by § 70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The label of a facial makeup preparation containing the color additive shall bear, in addition to other information required by the law, the following statement conspicuously displayed: Do not use in the area of the eye. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1, 2000]

Source:21 CFR 73.2995 · version 2026-08-27 · source checked 2026-08-30

Manganese violet

Manganese violet. (a) Identity. The color additive manganese violet is a violet pigment obtained by reacting phosphoric acid, ammonium dihydrogen orthophosphate, and manganese dioxide at temperatures above 450 °F. The pigment is a manganese ammonium pyrophosphate complex having the approximate formula: Mn(III)NH 4 P 2 O 7 . (b) Specifications. Manganese violet shall conform to the following specifications and shall be free from impurities other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Ash (at 600 °C), not less than 81 percent. Volatile matter at 135 °C for 3 hours, not more than 1 percent. Water soluble substances, not more than 6 percent. pH of filtrate of 10 grams color additive (shaken occasionally for 2 hours with 100 milliliters of freshly boiled distilled water), not more than 4.7 and not less than 2.5. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, based on Mn content in “as is” sample, not less than 93 percent. (c) Uses and restrictions. Manganese violet is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Conditions: Manganese violet. (a) Identity. The color additive manganese violet is a violet pigment obtained by reacting phosphoric acid, ammonium dihydrogen orthophosphate, and manganese dioxide at temperatures above 450 °F. The pigment is a manganese ammonium pyrophosphate complex having the approximate formula: Mn(III)NH 4 P 2 O 7 . (b) Specifications. Manganese violet shall conform to the following specifications and shall be free from impurities other than those named, to the extent that such other impurities may be avoided by good manufacturing practice: Ash (at 600 °C), not less than 81 percent. Volatile matter at 135 °C for 3 hours, not more than 1 percent. Water soluble substances, not more than 6 percent. pH of filtrate of 10 grams color additive (shaken occasionally for 2 hours with 100 milliliters of freshly boiled distilled water), not more than 4.7 and not less than 2.5. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, based on Mn content in “as is” sample, not less than 93 percent. (c) Uses and restrictions. Manganese violet is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Source:21 CFR 73.2775 · version 2026-08-27 · source checked 2026-08-30

Mica

CAS 12001-26-2 · EC 310-127-6 (I)

Mica. (a) Identity and specifications. The color additive mica shall conform in identity and specifications to the requirements of § 73.1496(a)(1) and (b). (b) Uses and restrictions. Mica is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 38561, July 29, 1977]

Conditions: Mica. (a) Identity and specifications. The color additive mica shall conform in identity and specifications to the requirements of § 73.1496(a)(1) and (b). (b) Uses and restrictions. Mica is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 38561, July 29, 1977]

Source:21 CFR 73.2496 · version 2026-08-27 · source checked 2026-08-30

Potassium sodium copper chlorophyllin (chlorophyllin-copper complex)

Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). (a) Identity and specifications. The color additive potassium sodium copper chlorophyllin shall conform in identity and specifications to the requirements of § 73.1125(a)(1) and (b). (b) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are cosmetics subject to the following conditions: (1) It shall not be used at a level in excess of 0.1 percent. (2) It may be used only in combination with the following substances: Water. Glycerin. Sodium carboxymethylcellulose. Tetrasodium pyrophosphate. Sorbitol. Magnesium phosphate, tribasic. Calcium carbonate. Calcium phosphate, dibasic. Sodium N -lauroyl sarcosinate. Artificial sweeteners that are generally recognized as safe or that are authorized under subchapter B of this chapter. Flavors that are generally recognized as safe or that are authorized under subchapter B of this chapter. Preservatives that are generally recognized as safe or that are authorized under subchapter B of this chapter. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Conditions: Potassium sodium copper chlorophyllin (chlorophyllin-copper complex). (a) Identity and specifications. The color additive potassium sodium copper chlorophyllin shall conform in identity and specifications to the requirements of § 73.1125(a)(1) and (b). (b) Uses and restrictions. Potassium sodium copper chlorophyllin may be safely used for coloring dentifrices that are cosmetics subject to the following conditions: (1) It shall not be used at a level in excess of 0.1 percent. (2) It may be used only in combination with the following substances: Water. Glycerin. Sodium carboxymethylcellulose. Tetrasodium pyrophosphate. Sorbitol. Magnesium phosphate, tribasic. Calcium carbonate. Calcium phosphate, dibasic. Sodium N -lauroyl sarcosinate. Artificial sweeteners that are generally recognized as safe or that are authorized under subchapter B of this chapter. Flavors that are generally recognized as safe or that are authorized under subchapter B of this chapter. Preservatives that are generally recognized as safe or that are authorized under subchapter B of this chapter. (c) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Source:21 CFR 73.2125 · version 2026-08-27 · source checked 2026-08-30

Pyrophyllite

CAS 12269-78-2 / 113349-10-3 / 113349-11-4 / 113349-12-5 / 141040-73-5 / 141040-74-6 · EC 215-475-1

Pyrophyllite. (a) Identity and specifications. The color additive pyrophyllite shall conform in identity and specifications to the requirements of § 73.1400 (a)(1) and (b). (b) Uses and restrictions. Pyrophyllite may be safely used for coloring externally applied cosmetics, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to all applicable requirements of law, including the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Conditions: Pyrophyllite. (a) Identity and specifications. The color additive pyrophyllite shall conform in identity and specifications to the requirements of § 73.1400 (a)(1) and (b). (b) Uses and restrictions. Pyrophyllite may be safely used for coloring externally applied cosmetics, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The labeling of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to all applicable requirements of law, including the requirements of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act.

Source:21 CFR 73.2400 · version 2026-08-27 · source checked 2026-08-30

Silver

CAS 7440-22-4 · EC 231-131-3

Silver. (a) Identity. (1) The color additive, silver, is a crystalline powder of high purity silver prepared by the reaction of silver nitrate with ferrous sulfate in the presence of nitric, phosphoric and sulfuric acids. Polyvinyl alcohol is used to prevent the agglomeration of crystals and the formation of amorphous silver. (2) Color additive mixtures of silver may contain only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Specifications. Silver shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 5 parts per million. Mercury (as Hg), not more than 1 part per million. Silver (as Ag), not less than 99.9 percent. (c) Uses and restrictions. The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product. (d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [44 FR 65974, Nov. 16, 1979]

Conditions: Silver. (a) Identity. (1) The color additive, silver, is a crystalline powder of high purity silver prepared by the reaction of silver nitrate with ferrous sulfate in the presence of nitric, phosphoric and sulfuric acids. Polyvinyl alcohol is used to prevent the agglomeration of crystals and the formation of amorphous silver. (2) Color additive mixtures of silver may contain only those diluents listed in § 73.1001(b) and, in addition, nitrocellulose. (b) Specifications. Silver shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 5 parts per million. Mercury (as Hg), not more than 1 part per million. Silver (as Ag), not less than 99.9 percent. (c) Uses and restrictions. The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product. (d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. [44 FR 65974, Nov. 16, 1979]

Source:21 CFR 73.2500 · version 2026-08-27 · source checked 2026-08-30

Silver nitrate

CAS 7761-88-8 · EC 231-853-9

Silver nitrate. (a) Identity. The color additive silver nitrate is a purified inorganic compound obtained as the recrystallized precipitate from the concentrated reaction mixture of silver and excess nitric acid at elevated temperatures, followed by drying the decanted, filtered, and washed crystals. The color additive has the chemical formula AgNO 3. (b) Specifications. Silver nitrate shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: (1) Arsenic, not more than 3 milligrams/kilogram (mg/kg) (3 parts per million (ppm)). (2) Cadmium, not more than 5 mg/kg (5 ppm). (3) Lead, not more than 10 mg/kg (10 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Volatile matter, calculated as water, not more than 0.1 percent. (6) Total color, not less than 99.9 percent. (c) Uses and restrictions. The color additive silver nitrate may be safely used in externally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes subject to the following restrictions: (1) The amount of silver nitrate in the cosmetic product shall not be more than 4 percent by weight. (2) The viscosity of the cosmetic formulation shall be not less than 120 Pascal-seconds (Pa⋅s) and not more than 180 Pa⋅s at normal temperature and pressure. (3) The cosmetic containing silver nitrate is not intended for use on persons under the age of 16. (4) Application of the cosmetic containing silver nitrate is not intended to exceed 1 minute and is intended to be followed by immediate removal. (5) The cosmetic containing silver nitrate is applied by a professional. (6) The cosmetic containing silver nitrate is not distributed or directly sold to consumers. (d) Labeling requirements. (1) The label of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter and include adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The label of any cosmetic containing the color additive silver nitrate, in addition to other information required by law, shall contain the following statements: Contains silver nitrate. Silver nitrate may permanently stain skin with which it comes into contact. Silver nitrate may irritate the eyes. For application by professionals only for dyeing eyebrows and eyelashes, in accordance with the directions for use. Not for use on persons under the age of 16. Apply to eyebrows and eyelashes for no more than 1 minute, followed by immediate removal. Rinse eyes immediately if product comes into contact with them. Consult a physician if any irritation persists. Not for distribution or direct sale to consumers. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification require]ments of section 721(c) of the Federal Food, Drug, and Cosmetic Act [86 FR 55498, Oct. 6, 2021]

Conditions: Silver nitrate. (a) Identity. The color additive silver nitrate is a purified inorganic compound obtained as the recrystallized precipitate from the concentrated reaction mixture of silver and excess nitric acid at elevated temperatures, followed by drying the decanted, filtered, and washed crystals. The color additive has the chemical formula AgNO 3. (b) Specifications. Silver nitrate shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice: (1) Arsenic, not more than 3 milligrams/kilogram (mg/kg) (3 parts per million (ppm)). (2) Cadmium, not more than 5 mg/kg (5 ppm). (3) Lead, not more than 10 mg/kg (10 ppm). (4) Mercury, not more than 1 mg/kg (1 ppm). (5) Volatile matter, calculated as water, not more than 0.1 percent. (6) Total color, not less than 99.9 percent. (c) Uses and restrictions. The color additive silver nitrate may be safely used in externally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes subject to the following restrictions: (1) The amount of silver nitrate in the cosmetic product shall not be more than 4 percent by weight. (2) The viscosity of the cosmetic formulation shall be not less than 120 Pascal-seconds (Pa⋅s) and not more than 180 Pa⋅s at normal temperature and pressure. (3) The cosmetic containing silver nitrate is not intended for use on persons under the age of 16. (4) Application of the cosmetic containing silver nitrate is not intended to exceed 1 minute and is intended to be followed by immediate removal. (5) The cosmetic containing silver nitrate is applied by a professional. (6) The cosmetic containing silver nitrate is not distributed or directly sold to consumers. (d) Labeling requirements. (1) The label of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter and include adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section. (2) The label of any cosmetic containing the color additive silver nitrate, in addition to other information required by law, shall contain the following statements: Contains silver nitrate. Silver nitrate may permanently stain skin with which it comes into contact. Silver nitrate may irritate the eyes. For application by professionals only for dyeing eyebrows and eyelashes, in accordance with the directions for use. Not for use on persons under the age of 16. Apply to eyebrows and eyelashes for no more than 1 minute, followed by immediate removal. Rinse eyes immediately if product comes into contact with them. Consult a physician if any irritation persists. Not for distribution or direct sale to consumers. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification require]ments of section 721(c) of the Federal Food, Drug, and Cosmetic Act [86 FR 55498, Oct. 6, 2021]

Source:21 CFR 73.2550 · version 2026-08-27 · source checked 2026-08-30

Titanium dioxide

CAS 13463-67-7 · EC 236-675-5

Titanium dioxide. (a) Identity and specifications. The color additive titanium dioxide shall conform in identity and specifications to the requirements on § 73.575 (a)(1) and (b). (b) Uses and restrictions. The color additive titanium dioxide may be safely used in cosmetics, including cosmetics intended for use in the ara of the eye, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Conditions: Titanium dioxide. (a) Identity and specifications. The color additive titanium dioxide shall conform in identity and specifications to the requirements on § 73.575 (a)(1) and (b). (b) Uses and restrictions. The color additive titanium dioxide may be safely used in cosmetics, including cosmetics intended for use in the ara of the eye, in amounts consistent with good manufacturing practice. (c) Labeling requirements. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Source:21 CFR 73.2575 · version 2026-08-27 · source checked 2026-08-30

Ultramarines

CAS 1302-83-6 / 1317-97-1 / 1345-00-2 / 11118-33-5 / 12703-66-1 / 12769-96-9 / 57455-37-5 · EC 215-111-1 / 215-711-3 / 235-811-0 / - / - / - / -

Ultramarines. (a) Identity. The color additives, ultramarines (blue, green, pink, red, and violet) are pigments obtained by calcining at temperatures above 700 °C. a mixture of kaolin, sulfur, sodium carbonate, silicious matter, sodium sulfate, and carbonaceous matter, but not necessarily all these substances, to produce a single color. The ultramarines are complex sodium aluminum sulfosilicates having a typical formula Na(AlSiO)S with proportions of each element varying with each color. (b) Specifications. The ultramarines shall conform to the following specifications and shall be free from impurities other than those named, to the extent that such other impurities may be avoided by good manufacturing practice. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. The ultramarine pigments may be safely used for coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling requirements. The color additives and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Conditions: Ultramarines. (a) Identity. The color additives, ultramarines (blue, green, pink, red, and violet) are pigments obtained by calcining at temperatures above 700 °C. a mixture of kaolin, sulfur, sodium carbonate, silicious matter, sodium sulfate, and carbonaceous matter, but not necessarily all these substances, to produce a single color. The ultramarines are complex sodium aluminum sulfosilicates having a typical formula Na(AlSiO)S with proportions of each element varying with each color. (b) Specifications. The ultramarines shall conform to the following specifications and shall be free from impurities other than those named, to the extent that such other impurities may be avoided by good manufacturing practice. Lead (as Pb), not more than 20 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Uses and restrictions. The ultramarine pigments may be safely used for coloring externally applied cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (d) Labeling requirements. The color additives and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any other information required by law, labeling in accordance with § 70.25 of this chapter. (e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from certification pursuant to section 721(c) of the act.

Source:21 CFR 73.2725 · version 2026-08-27 · source checked 2026-08-30

Use of aerosol cosmetic products containing zirconium

Use of aerosol cosmetic products containing zirconium. (a) Zirconium-containing complexes have been used as an ingredient in cosmetics and/or cosmetics that are also drugs, as, for example, aerosol antiperspirants. Evidence indicates that certain zirconium compounds have caused human skin granulomas and toxic effects in the lungs and other organs of experimental animals. When used in aerosol form, some zirconium will reach the deep portions of the lungs of users. The lung is an organ, like skin, subject to the development of granulomas. Unlike the skin, the lung will not reveal the presence of granulomatous changes until they have become advanced and, in some cases, permanent. It is the view of the Commissioner that zirconium is a deleterious substance that may render any cosmetic aerosol product that contains it injurious to users. (b) Any aerosol cosmetic product containing zirconium is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. (c) Any such cosmetic product introduced in interstate commerce after September 15, 1977 is subject to regulatory action. [42 FR 41376, Aug. 16, 1977]

Source:21 CFR 700.16 · version 2026-08-27 · source checked 2026-08-30

Use of certain halogenated salicylanilides as ingredients in cosmetic products

Use of certain halogenated salicylanilides as ingredients in cosmetic products. (a) Halogenated salicylanilides (tribromsalan (TBS,3,4′,5-tribromosalicylanilide), dibromsalan (DBS,4′5-dibromosalicylanilide), metabromsalan (MBS, 3,5-dibromosalicylanilide) and 3,3′,4,5′-tetrachlorosalicylanilide (TCSA)) have been used as antimicrobial agents for a variety of purposes in cosmetic products. These halogenated salicylanilides are potent photosensitizers and cross-sensitizers and can cause disabling skin disorders. In some instances, the photosensitization may persist for prolonged periods as a severe reaction without further exposure to these chemicals. Safer alternative antimicrobial agents are available. (b) These halogenated salicylanilides are deleterious substances which render any cosmetic that contains them injurious to users. Therefore, any cosmetic product that contains such a halogenated salicylanilide as an ingredient at any level for any purpose is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. (c) Any cosmetic product containing these halogenated salicylanilides as an ingredient that is initially introduced into interstate commerce after December 1, 1975, that is not in compliance with this section is subject to regulatory action. [40 FR 50531, Oct. 30, 1975]

Source:21 CFR 700.15 · version 2026-08-27 · source checked 2026-08-30

Use of chloroform as an ingredient in cosmetic products

Use of chloroform as an ingredient in cosmetic products. (a) Chloroform has been used as an ingredient in cosmetic products. Recent information has become available associating chloroform with carcinogenic effects in animals. Studies conducted by the National Cancer Institute have demonstrated that the oral administration of chloroform to mice and rats induced hepatocellular carcinomas (liver cancer) in mice and renal tumors in male rats. Scientific literature indicates that chloroform is absorbed from the gastrointestinal tract, through the respiratory system, and through the skin. The Commissioner concludes that, on the basis of these findings, chloroform is a deleterious substance which may render injurious to users any cosmetic product that contains chloroform as an ingredient. (b) Any cosmetic product containing chloroform as an ingredient is adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic Act. Any cosmetic product containing chloroform in residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient, is not, for the purpose of this section, considered to contain chloroform as an ingredient. [41 FR 26845, June 29, 1976]

Source:21 CFR 700.18 · version 2026-08-27 · source checked 2026-08-30

Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs

Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs. (a) Mercury-containing cosmetic preparations have been represented for many years as skin-bleaching agents or as preparations to remove or prevent freckles and/or brown spots (so-called age spots). Preparations intended for such use are regarded as drugs as well as cosmetics. In addition to such use as skin-bleaching agents, mercury compounds have also been widely used as preservatives in cosmetics such as hand and body creams and lotions; hair shampoos, hair sets and rinses, hair straighteners, hair coloring, and other preparations; bath oils, bubble bath, and other bath preparations; makeup; antiperspirants and deodorants; and eye-area cosmetics. (b) The toxicity of mercury compounds is extensively documented in scientific literature. It is well known that mercury compounds are readily absorbed through the unbroken skin as well as through the lungs by inhalation and by intestinal absorption after ingestion. Mercury is absorbed from topical application and is accumulated in the body, giving rise to numerous adverse effects. Mercury is a potent allergen and sensitizer, and skin irritation is common after topical application. Cosmetic preparations containing mercury compounds are often applied with regularity and frequency for prolonged periods. Such chronic use of mercury-containing skin-bleaching preparations has resulted in the accumulation of mercury in the body and the occurrence of severe reactions. Recently it has also been determined that microorganisms in the environment can convert various forms of mercury into highly toxic methyl mercury which has been found in the food supply and is now considered to be a serious environmental problem. (c) The effectiveness of mercury-containing preparations as skin-bleaching agents is questionable. The Food and Drug Administration has not been provided with well controlled studies to document the effectiveness of these preparations. Although mercurial preservatives are recognized as highly effective, less toxic and satisfactory substitutes are available except in the case of certain eye-area cosmetics. (d) Because of the known hazards of mercury, its questionable efficacy as a skin-bleaching agent, and the availability of effective and less toxic nonmercurial preservatives, there is no justification for the use of mercury in skin-bleaching preparations or its use as a preservative in cosmetics, with the exception of eye-area cosmetics for which no other effective and safe nonmercurial preservative is available. The continued use of mercurial preservatives in such eye-area cosmetics is warranted because mercury compounds are exceptionally effective in preventing Pseudomonas contamination of cosmetics and Pseudomonas infection of the eye can cause serious injury, including blindness. Therefore: (1) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-9 (issued May 13, 1939) and concludes that any product containing mercury as a skin-bleaching agent and offered for sale as skin-bleaching, beauty, or facial preparation is misbranded within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j), and may be a new drug without approval in violation of section 505 of the Federal Food, Drug, and Cosmetic Act. Any such preparation shipped within the jurisdiction of the Act after January 5, 1973 will be the subject of regulatory action. (2) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as adulterated within the meaning of section 601(a) of the Act any cosmetic containing mercury unless the cosmetic meets the conditions of paragraph (d)(2) (i) or (ii) of this section. (i) It is a cosmetic containing no more than a trace amount of mercury and such trace amount is unavoidable under conditions of good manufacturing practice and is less than 1 part per million (0.0001 percent), calculated as the metal; or (ii) It is a cosmetic intended for use only in the area of the eye, it contains no more than 65 parts per million (0.0065 percent) of mercury, calculated as the metal, as a preservative, and there is no effective and safe nonmercurial substitute preservative available for use in such cosmetic.

Source:21 CFR 700.13 · version 2026-08-27 · source checked 2026-08-30

Use of methylene chloride as an ingredient of cosmetic products

Use of methylene chloride as an ingredient of cosmetic products. (a) Methylene chloride has been used as an ingredient of aerosol cosmetic products, principally hair sprays, at concentrations generally ranging from 10 to 25 percent. In a 2-year animal inhalation study sponsored by the National Toxicology Program, methylene chloride produced a significant increase in benign and malignant tumors of the lung and liver of male and female mice. Based on these findings and on estimates of human exposure from the customary use of hair sprays, the Food and Drug Administration concludes that the use of methylene chloride in cosmetic products poses a significant cancer risk to consumers, and that the use of this ingredient in cosmetic products may render these products injurious to health. (b) Any cosmetic product that contains methylene chloride as an ingredient is deemed adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic Act. [54 FR 27342, June 29, 1989]

Source:21 CFR 700.19 · version 2026-08-27 · source checked 2026-08-30

Use of prohibited cattle materials in cosmetic products

Use of prohibited cattle materials in cosmetic products. (a) Definitions. The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply to such terms when used in this part. The following definitions also apply: (1) Prohibited cattle materials mean specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). Prohibited cattle materials do not include the following: (i) Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, and (ii) Cattle materials inspected and passed from a country designated under paragraph (e) of this section. (2) Inspected and passed means that the product has been inspected and passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulterated. (3) Mechanically separated (MS) (Beef) means a meat food product that is finely comminuted, resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses that meets the specifications contained in 9 CFR 319.5, the U.S. Department of Agriculture regulation that prescribes the standard of identity for MS (Species). (4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions. (5) Specified risk material means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older and the tonsils and distal ileum of the small intestine of all cattle. (6) Tallow means the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain no more than 0.15 percent insoluble impurities as determined by the method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from AOCS ( http://www.aocs.org ) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (7) Tallow derivative means any chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product. (8) Gelatin means a product that has been obtained by the partial hydrolysis of collagen derived from hides, connective tissue, and/or bone bones of cattle and swine. Gelatin may be either Type A (derived from an acid-treated precursor) or Type B (derived from an alkali-treated precursor) that has gone through processing steps that include filtration and sterilization or an equivalent process in terms of infectivity reduction. (b) Requirements. (1) No cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials. (2) The small intestine is not considered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine, as measured from the caeco-colic junction and progressing proximally towards the jejunum, or by a procedure that the establishment can demonstrate is equally effective in ensuring complete removal of the distal ileum. (c) Records. (1) Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. (2) Records must be retained for 2 years after the date they were created. (3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location. (4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location. (5) Records required by this section and existing records relevant to compliance with this section must be available to FDA for inspection and copying. (6) When filing entry with U.S. Customs and Border Protection, the importer of record of a cosmetic manufactured from, processed with, or otherwise containing, cattle material must affirm that the cosmetic was manufactured from, processed with, or otherwise contains, cattle material and must affirm that the cosmetic was manufactured in accordance with this section. If a cosmetic is manufactured from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle material. (7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter. (d) Adulteration. Failure of a manufacturer or processor to operate in compliance with the requirements of paragraph (b) or (c) of this section renders a cosmetic adulterated under section 601(c) of the act. (e) Process for designating countries. A country seeking designation must send a written request to the Director, Office of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, at the address designated in 21 CFR 5.1100. The request shall include information about a country's bovine spongiform encephalopathy (BSE) case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether specified risk materials, the small intestine of cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, or MS (Beef) from cattle from the country should be considered prohibited cattle materials. FDA shall respond in writing to any such request and may impose conditions in granting any such request. A country designation granted by FDA under this paragraph will be subject to future review by FDA, and may be revoked if FDA determines that it is no longer appropriate. [70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 73 FR 20794, Apr. 17, 2008; 81 FR 5596, Feb. 3, 2016; 81 FR 14732, Mar. 18, 2016]

Source:21 CFR 700.27 · version 2026-08-27 · source checked 2026-08-30

Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products

Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products. (a) Vinyl chloride has been used as an ingredient in cosmetic aerosol products including hair sprays. Where such aerosol products are used in the confines of a small room, as is often the case, the level of vinyl chloride to which the individual may be exposed could be significantly in excess of the safe level established in connection with occupational exposure. Evidence indicates that vinyl chloride inhalation can result in acute toxicity, manifested by dizziness, headache, disorientation, and unconsciousness where inhaled at high concentrations. Studies also demonstrate carcinogenic effects in animals as a result of inhalation exposure to vinyl chloride. Furthermore, vinyl chloride has recently been linked to liver disease, including liver cancer, in workers engaged in the polymerization of vinyl chloride. It is the view of the Commissioner that vinyl chloride is a deleterious substance which may render any cosmetic aerosol product that contains it as an ingredient injurious to users. Accordingly, any cosmetic aerosol product containing vinyl chloride as an ingredient is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. (b) Any cosmetic aerosol product containing vinyl chloride as an ingredient shipped within the jurisdiction of the Act is subject to regulatory action. [39 FR 30830, Aug. 26, 1974]

Source:21 CFR 700.14 · version 2026-08-27 · source checked 2026-08-30

Zinc oxide

CAS 1314-13-2 · EC 215-222-5

Zinc oxide. (a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of § 73.1991 (a)(1) and (b). (b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37538, July 22, 1977]

Conditions: Zinc oxide. (a) Identity and specifications. The color additive zinc oxide shall conform in identity and specifications to the requirements of § 73.1991 (a)(1) and (b). (b) Uses and restrictions. Zinc oxide may be safely used in cosmetics, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 37538, July 22, 1977]

Source:21 CFR 73.2991 · version 2026-08-27 · source checked 2026-08-30

β-Carotene

β-Carotene. (a) Identity and specifications. The color additive β-carotene shall conform in identity and specifications to the requirements of § 73.95(a)(1) and (b). (b) Uses and restrictions. The color additive β-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 33722, July 1, 1977]

Conditions: β-Carotene. (a) Identity and specifications. The color additive β-carotene shall conform in identity and specifications to the requirements of § 73.95(a)(1) and (b). (b) Uses and restrictions. The color additive β-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices. (c) Labeling. The color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches therof are exempt from the certification pursuant to section 721(c) of the act. [42 FR 33722, July 1, 1977]

Source:21 CFR 73.2095 · version 2026-08-27 · source checked 2026-08-30