United States cosmetic ingredient regulations

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

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