United States cosmetic ingredient regulations

Aluminum powder

Aluminum powder. (a) Identity and specifications. The color additive aluminum powder shall conform in identity and specifications to the requirements of § 73.1645 (a)(1) and (b). (b) Uses and restrictions. Aluminum powder may be safely used in coloring externally applied 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 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 38563, July 29, 1977]

Conditions: Aluminum powder. (a) Identity and specifications. The color additive aluminum powder shall conform in identity and specifications to the requirements of § 73.1645 (a)(1) and (b). (b) Uses and restrictions. Aluminum powder may be safely used in coloring externally applied 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 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 38563, July 29, 1977]

Source:21 CFR 73.2645 · version 2026-08-27 · source checked 2026-08-30

Annatto

Annatto. (a) Identity and specification. The color additive annatto shall conform in identify and specification to the requirements for annatto extract in § 73.30(a) (1) and (b). (b) Use and restriction. The color additive annatto 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 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 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 requirements of section 721(c) of the act. [42 FR 36994, July 19, 1977]

Conditions: Annatto. (a) Identity and specification. The color additive annatto shall conform in identify and specification to the requirements for annatto extract in § 73.30(a) (1) and (b). (b) Use and restriction. The color additive annatto 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 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 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 requirements of section 721(c) of the act. [42 FR 36994, July 19, 1977]

Source:21 CFR 73.2030 · version 2026-08-27 · source checked 2026-08-30

Bismuth citrate

CAS 813-93-4 · EC 212-390-1

Bismuth citrate. (a) Identity. The color additive bismuth citrate is the synthetically prepared crystalline salt of bismuth and citric acid, consisting principally of BiC 6 H 5 O 7 . (b) Specifications. The color additive bismuth citrate shall conform to the following specifications and shall be free from impurities other than those named to the extent that those impurities may be avoided by good manufacturing practice: Bismuth citrate, not less than 97 percent. Mercury (as Hg), not more than 1 part per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 20 parts per million. Volatile matter, not more than 1 percent. (c) Uses and restrictions. The color additive bismuth citrate may be safely used in cosmetics intended for coloring hair on the scalp, subject to the following restrictions: (1) The amount of bismuth citrate in the cosmetic shall not be in excess of 2.0 percent (w/v). (2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp. (d) Labeling. (1) The label of the color additive bismuth citrate shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed thereon: Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use. (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 certification requirements of section 721(c) of the act. [43 FR 44831, Sept. 29, 1978, as amended at 75 FR 14493, Mar. 26, 2010]

Conditions: Bismuth citrate. (a) Identity. The color additive bismuth citrate is the synthetically prepared crystalline salt of bismuth and citric acid, consisting principally of BiC 6 H 5 O 7 . (b) Specifications. The color additive bismuth citrate shall conform to the following specifications and shall be free from impurities other than those named to the extent that those impurities may be avoided by good manufacturing practice: Bismuth citrate, not less than 97 percent. Mercury (as Hg), not more than 1 part per million. Arsenic (as As), not more than 3 parts per million. Lead (as Pb), not more than 20 parts per million. Volatile matter, not more than 1 percent. (c) Uses and restrictions. The color additive bismuth citrate may be safely used in cosmetics intended for coloring hair on the scalp, subject to the following restrictions: (1) The amount of bismuth citrate in the cosmetic shall not be in excess of 2.0 percent (w/v). (2) The cosmetic may not be used for coloring eyelashes, eyebrows, or hair on parts of the body other than the scalp. (d) Labeling. (1) The label of the color additive bismuth citrate shall bear, in addition to any information required by law, labeling in accordance with the provisions of § 70.25 of this chapter. (2) The label of a cosmetic containing the color additive bismuth citrate shall bear, in addition to other information required by law, the following statement, conspicuously displayed thereon: Keep this product out of children's reach. Do not use on cut or abraded scalp. Do not use to color eyelashes, eyebrows, or hair on parts of the body other than the scalp. Wash hands thoroughly after each use. (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 certification requirements of section 721(c) of the act. [43 FR 44831, Sept. 29, 1978, as amended at 75 FR 14493, Mar. 26, 2010]

Source:21 CFR 73.2110 · version 2026-08-27 · source checked 2026-08-30

Bismuth oxychloride

Bismuth oxychloride. (a) Identity and specifications. (1) The color additive bismuth oxychloride shall conform in identity and specifications to the requirements of § 73.1162(a)(1) and (b). (2) Color additive mixtures of bismuth oxychloride 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) Uses and restrictions. The color additive bismuth oxychloride 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 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 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. [42 FR 52394, Sept. 30, 1977]

Conditions: Bismuth oxychloride. (a) Identity and specifications. (1) The color additive bismuth oxychloride shall conform in identity and specifications to the requirements of § 73.1162(a)(1) and (b). (2) Color additive mixtures of bismuth oxychloride 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) Uses and restrictions. The color additive bismuth oxychloride 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 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 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. [42 FR 52394, Sept. 30, 1977]

Source:21 CFR 73.2162 · version 2026-08-27 · source checked 2026-08-30

Bronze powder

Bronze powder. (a) Identity and specifications. The color additive bronze powder shall conform in identity and specifications to the requirements of § 73.1646 (a)(1) and (b). (b) Uses and restrictions. Bronze powder 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 practice. (c) Labeling. 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. (d) Exemption from certification. Certification of the 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. [42 FR 33724, July 1, 1977]

Conditions: Bronze powder. (a) Identity and specifications. The color additive bronze powder shall conform in identity and specifications to the requirements of § 73.1646 (a)(1) and (b). (b) Uses and restrictions. Bronze powder 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 practice. (c) Labeling. 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. (d) Exemption from certification. Certification of the 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. [42 FR 33724, July 1, 1977]

Source:21 CFR 73.2646 · version 2026-08-27 · source checked 2026-08-30

Caramel

CAS 8028-89-5 · EC 232-435-9

Caramel. (a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of § 73.85(a)(1), (2), and (3) and (b). (b) Uses and restrictions. Caramel 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 requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom 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 requirement of section 721(c) of the act. [46 FR 38501, July 28, 1981]

Conditions: Caramel. (a) Identity and specifications. The color additive caramel shall conform in identity and specifications to the requirements of § 73.85(a)(1), (2), and (3) and (b). (b) Uses and restrictions. Caramel 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 requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom 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 requirement of section 721(c) of the act. [46 FR 38501, July 28, 1981]

Source:21 CFR 73.2085 · version 2026-08-27 · source checked 2026-08-30

Carmine

Carmine. (a) Identity and specifications. The color additive carmine shall conform in identity and specifications to the requirements of § 73.100 (a)(2) and (b)(2). (b) Use and restrictions. Carmine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices. (c) Labeling. (1) 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. (2) Cosmetics containing carmine that are not subject to the requirements of § 701.3 of this chapter shall specifically declare the presence of carmine prominently and conspicuously at least once in the labeling. For example: “Contains carmine as a color additive.” (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 32228, June 24, 1977, as amended at 74 FR 216, Jan. 5, 2009]

Conditions: Carmine. (a) Identity and specifications. The color additive carmine shall conform in identity and specifications to the requirements of § 73.100 (a)(2) and (b)(2). (b) Use and restrictions. Carmine may be safely used in cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practices. (c) Labeling. (1) 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. (2) Cosmetics containing carmine that are not subject to the requirements of § 701.3 of this chapter shall specifically declare the presence of carmine prominently and conspicuously at least once in the labeling. For example: “Contains carmine as a color additive.” (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 32228, June 24, 1977, as amended at 74 FR 216, Jan. 5, 2009]

Source:21 CFR 73.2087 · version 2026-08-27 · source checked 2026-08-30

Chlorofluorocarbon propellants

Chlorofluorocarbon propellants. The use of chlorofluorocarbons in cosmetics as propellants in self-pressurized containers is prohibited as provided in § 2.125 of this chapter. [43 FR 11317, Mar. 17, 1978]

Source:21 CFR 700.23 · version 2026-08-27 · source checked 2026-08-30

Chromium hydroxide green

Chromium hydroxide green. (a) Identity and specifications. The color additive chromium hydroxide green shall conform in identity and specifications to the requirements of § 73.1326 (a)(1) and (b). (b) Uses and restrictions. Chromium hydroxide green is safe for use in coloring externally applied cosmetics, including those 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 certification pursuant to section 721(c) of the act. [42 FR 36452, July 15, 1977]

Conditions: Chromium hydroxide green. (a) Identity and specifications. The color additive chromium hydroxide green shall conform in identity and specifications to the requirements of § 73.1326 (a)(1) and (b). (b) Uses and restrictions. Chromium hydroxide green is safe for use in coloring externally applied cosmetics, including those 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 certification pursuant to section 721(c) of the act. [42 FR 36452, July 15, 1977]

Source:21 CFR 73.2326 · version 2026-08-27 · source checked 2026-08-30

Chromium oxide greens

Chromium oxide greens. (a) Identity and specifications. The color additive chromium oxide greens shall conform in identify and specifications to the requirements of § 73.1327 (a)(1) and (b). (b) Uses and restrictions. The color additive chromium oxide greens may be safely used in externally applied cosmetics, 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 36452, July 15, 1977]

Conditions: Chromium oxide greens. (a) Identity and specifications. The color additive chromium oxide greens shall conform in identify and specifications to the requirements of § 73.1327 (a)(1) and (b). (b) Uses and restrictions. The color additive chromium oxide greens may be safely used in externally applied cosmetics, 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 36452, July 15, 1977]

Source:21 CFR 73.2327 · version 2026-08-27 · source checked 2026-08-30

Copper powder

Copper powder. (a) Identity and specifications. The color additive copper powder shall conform in identity and specifications to the requirements of § 73.1647 (a)(1) and (b). (b) Uses and restrictions. Copper powder 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 practice. (c) Labeling. 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. (d) Exemption from certification. Certification of the 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. [42 FR 33724, July 1, 1977]

Conditions: Copper powder. (a) Identity and specifications. The color additive copper powder shall conform in identity and specifications to the requirements of § 73.1647 (a)(1) and (b). (b) Uses and restrictions. Copper powder 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 practice. (c) Labeling. 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. (d) Exemption from certification. Certification of the 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. [42 FR 33724, July 1, 1977]

Source:21 CFR 73.2647 · version 2026-08-27 · source checked 2026-08-30

Cosmetics containing bithionol

Cosmetics containing bithionol. (a) Bithionol has been used to some extent as an antibacterial agent in cosmetic preparations such as detergent bars, shampoos, creams, lotions, and bases used to hide blemishes. New evidence of clinical experience and photopatch tests indicate that bithionol is capable of causing photosensitivity in man when used topically and that in some instances the photosensitization may persist for prolonged periods as severe reactions without further contact with sensitizing articles. Also, there is evidence to indicate that bithionol may produce cross-sensitization with other commonly used chemicals such as certain halogenated salicylanilides and hexachlorophene. It is, therefore, the view of the Food and Drug Administration that bithionol is a deleterious substance which may render any cosmetic product that contains it injurious to users. Accordingly, any cosmetic containing bithionol is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. (b) Regulatory proceedings may be initiated with respect to any cosmetic preparation containing bithionol shipped within the jurisdiction of the act after March 15, 1968.

Source:21 CFR 700.11 · version 2026-08-27 · source checked 2026-08-30

D&C Black No. 2

D&C Black No. 2. (a) Identity. The color additive D&C Black No. 2 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 200 to 260 meters (m) 2 /gram. (b) Specifications. D&C Black No. 2 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: (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m 2 /gram. (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent. (3) Ash content, not more than 0.15 percent. (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million). (5) Lead (total), not more than 10 mg/kg (10 parts per million). (6) Mercury (total), not more than 1 mg/kg (1 part per million). (7) Total sulfur, not more than 0.65 percent. (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion). (9) Benzo[ a ]pyrene, not more than 0.005 mg/kg (5 parts per billion). (10) Dibenz[ a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion). (11) Total color (as carbon), not less than 95 percent. (c) Uses and restrictions. D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 2 shall be certified in accordance with regulations in part 80 of this chapter. [69 FR 44930, July 28, 2004, as amended at 72 FR 10357]

Conditions: D&C Black No. 2. (a) Identity. The color additive D&C Black No. 2 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 200 to 260 meters (m) 2 /gram. (b) Specifications. D&C Black No. 2 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: (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m 2 /gram. (2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent. (3) Ash content, not more than 0.15 percent. (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million). (5) Lead (total), not more than 10 mg/kg (10 parts per million). (6) Mercury (total), not more than 1 mg/kg (1 part per million). (7) Total sulfur, not more than 0.65 percent. (8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion). (9) Benzo[ a ]pyrene, not more than 0.005 mg/kg (5 parts per billion). (10) Dibenz[ a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion). (11) Total color (as carbon), not less than 95 percent. (c) Uses and restrictions. D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 2 shall be certified in accordance with regulations in part 80 of this chapter. [69 FR 44930, July 28, 2004, as amended at 72 FR 10357]

Source:21 CFR 74.2052 · version 2026-08-27 · source checked 2026-08-30

D&C Black No. 3

D&C Black No. 3. (a) Identity. The color additive D&C Black No. 3 is a washed bone char prepared from calcined cattle bones. The bones are twice heated in excess of 700 °C for at least 6 hours. (b) Specifications. D&C Black No. 3 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 current good manufacturing practices: (1) Calcium hydroxyapatite (CaO and P 2 O 5 ), not less than 75 percent and not more than 84 percent; (2) Elemental carbon, not less than 7 percent; (3) Moisture, not more than 7 percent; (4) Silica (SiO 2 ), not more than 5 percent; (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm)); (6) Lead, not more than 10 mg/kg (10 ppm); and (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must comply with § 700.27 of this chapter with respect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, eye shadow, mascara, and face powder. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [72 FR 33666, June 19, 2007]

Conditions: D&C Black No. 3. (a) Identity. The color additive D&C Black No. 3 is a washed bone char prepared from calcined cattle bones. The bones are twice heated in excess of 700 °C for at least 6 hours. (b) Specifications. D&C Black No. 3 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 current good manufacturing practices: (1) Calcium hydroxyapatite (CaO and P 2 O 5 ), not less than 75 percent and not more than 84 percent; (2) Elemental carbon, not less than 7 percent; (3) Moisture, not more than 7 percent; (4) Silica (SiO 2 ), not more than 5 percent; (5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm)); (6) Lead, not more than 10 mg/kg (10 ppm); and (7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm). (c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must comply with § 700.27 of this chapter with respect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, eye shadow, mascara, and face powder. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of D&C Black No. 3 shall be certified in accordance with regulations in part 80 of this chapter. [72 FR 33666, June 19, 2007]

Source:21 CFR 74.2053 · version 2026-08-27 · source checked 2026-08-30

D&C Blue No. 4

D&C Blue No. 4. (a) Identity and specifications. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b). (b) Uses and restrictions. D&C Blue 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 D&C Blue No. 4 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Blue No. 4. (a) Identity and specifications. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b). (b) Uses and restrictions. D&C Blue 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 D&C Blue No. 4 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2104 · version 2026-08-27 · source checked 2026-08-30

D&C Blue No. 4

D&C Blue No. 4. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b) of this chapter. D&C Blue No. 4 is restricted to use in externally applied drugs and cosmetics.

Conditions: D&C Blue No. 4. The color additive D&C Blue No. 4 shall conform in identity and specifications to the requirements of § 74.1104(a)(1) and (b) of this chapter. D&C Blue No. 4 is restricted to use in externally applied drugs and cosmetics.

Source:21 CFR 82.1104 · version 2026-08-27 · source checked 2026-08-30

D&C Brown No. 1

D&C Brown No. 1. (a) Identity. The color additive D&C Brown No. 1 is a mixture of the sodium salts of 4[[5-[(dialkylphenyl)- azo]-2,4-dihydroxyphenyl]azo]-benzene sulfonic acid. The alkyl group is principally the methyl group. (b) Specifications. D&C Brown No. 1 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) and chlorides and sulfates (calculated as sodium salts), not more than 16 percent. Water-insoluble matter, not more than 0.2 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Resorcinol, not more than 0.2 percent. Xylidines, not more than 0.2 percent. Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not more than 3 percent. Monosodium salt of 4[[5-[(2,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 29 percent and not more than 39 percent. Monosodium salt of 4[[5-[(2,5-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 12 percent and not more than 17 percent. Monosodium salt of 4[[5-[(2,3-dimethyl-phenyl)azo] - 2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 6 percent and not more than 13 percent. Monosodium salt of 4[[5-[(2-ethylphenyl)-azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 5 percent and not more than 12 percent. Monosodium salt of 4[[5-[(3,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 9 percent. Monosodium salt of 4[[5-[(2,6-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 8 percent. Monosodium salt of 4[[5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 2 percent and not more than 8 percent. 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 84 percent. (c) Uses and restrictions. D&C Brown No. 1 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 D&C Brown No. 1 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Brown No. 1. (a) Identity. The color additive D&C Brown No. 1 is a mixture of the sodium salts of 4[[5-[(dialkylphenyl)- azo]-2,4-dihydroxyphenyl]azo]-benzene sulfonic acid. The alkyl group is principally the methyl group. (b) Specifications. D&C Brown No. 1 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) and chlorides and sulfates (calculated as sodium salts), not more than 16 percent. Water-insoluble matter, not more than 0.2 percent. Sulfanilic acid, sodium salt, not more than 0.2 percent. Resorcinol, not more than 0.2 percent. Xylidines, not more than 0.2 percent. Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not more than 3 percent. Monosodium salt of 4[[5-[(2,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 29 percent and not more than 39 percent. Monosodium salt of 4[[5-[(2,5-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 12 percent and not more than 17 percent. Monosodium salt of 4[[5-[(2,3-dimethyl-phenyl)azo] - 2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 6 percent and not more than 13 percent. Monosodium salt of 4[[5-[(2-ethylphenyl)-azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 5 percent and not more than 12 percent. Monosodium salt of 4[[5-[(3,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 9 percent. Monosodium salt of 4[[5-[(2,6-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 8 percent. Monosodium salt of 4[[5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 2 percent and not more than 8 percent. 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 84 percent. (c) Uses and restrictions. D&C Brown No. 1 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 D&C Brown No. 1 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2151 · version 2026-08-27 · source checked 2026-08-30

D&C Green No. 5

D&C Green No. 5. (a) Identity and specifications. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of § 74.1205 (a)(1) and (b)(2). (b) Uses and restrictions. D&C Green 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. (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 Green No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 24285, June 4, 1982, as amended at 59 FR 40805, Aug. 10, 1994]

Conditions: D&C Green No. 5. (a) Identity and specifications. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of § 74.1205 (a)(1) and (b)(2). (b) Uses and restrictions. D&C Green 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. (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 Green No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 24285, June 4, 1982, as amended at 59 FR 40805, Aug. 10, 1994]

Source:21 CFR 74.2205 · version 2026-08-27 · source checked 2026-08-30

D&C Green No. 5

D&C Green No. 5. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of § 74.1205(a)(1) and (b)(2) of this chapter. [47 FR 24285, June 4, 1982]

Conditions: D&C Green No. 5. The color additive D&C Green No. 5 shall conform in identity and specifications to the requirements of § 74.1205(a)(1) and (b)(2) of this chapter. [47 FR 24285, June 4, 1982]

Source:21 CFR 82.1205 · version 2026-08-27 · source checked 2026-08-30

D&C Green No. 6

D&C Green No. 6. (a) Identity and specifications. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b). (b) Uses and restrictions. D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Green No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986]

Conditions: D&C Green No. 6. (a) Identity and specifications. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b). (b) Uses and restrictions. D&C Green No. 6 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Green No. 6 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 14146, Apr. 4, 1982, as amended at 51 FR 9784, Mar. 21, 1986]

Source:21 CFR 74.2206 · version 2026-08-27 · source checked 2026-08-30

D&C Green No. 6

D&C Green No. 6. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b) of this chapter. D&C Green No. 6 is restricted to use in externally applied drugs and cosmetics. [47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986]

Conditions: D&C Green No. 6. The color additive D&C Green No. 6 shall conform in identity and specifications to the requirements of § 74.1206 (a) and (b) of this chapter. D&C Green No. 6 is restricted to use in externally applied drugs and cosmetics. [47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986]

Source:21 CFR 82.1206 · version 2026-08-27 · source checked 2026-08-30

D&C Green No. 8

D&C Green No. 8. (a) Identity and specifications. The color additive D&C Green No. 8 shall conform in identity and specifications to the requirements of § 74.1208(a)(1) and (b). (b) Uses and restrictions. D&C Green No. 8 may be safely used for coloring externally applied cosmetics in amounts not exceeding 0.01 percent by weight of the finished cosmetic product. (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 Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Green No. 8. (a) Identity and specifications. The color additive D&C Green No. 8 shall conform in identity and specifications to the requirements of § 74.1208(a)(1) and (b). (b) Uses and restrictions. D&C Green No. 8 may be safely used for coloring externally applied cosmetics in amounts not exceeding 0.01 percent by weight of the finished cosmetic product. (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 Green No. 8 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2208 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 10

D&C Orange No. 10. (a) Identity and specifications. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements of § 74.1260(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 10 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981]

Conditions: D&C Orange No. 10. (a) Identity and specifications. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements of § 74.1260(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 10 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981]

Source:21 CFR 74.2260 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 10

D&C Orange No. 10. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements to § 74.1260(a)(1) and (b) of this chapter. D&C Orange No. 10 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981]

Conditions: D&C Orange No. 10. The color additive D&C Orange No. 10 shall conform in identity and specifications to the requirements to § 74.1260(a)(1) and (b) of this chapter. D&C Orange No. 10 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981]

Source:21 CFR 82.1260 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 11

D&C Orange No. 11. (a) Identity and specifications. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981]

Conditions: D&C Orange No. 11. (a) Identity and specifications. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 11 may be safely used for coloring externally applied cosmetics in amounts consistent with 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 Orange No. 11 shall be certified in accordance with regulations in part 80 of this chapter. [46 FR 18954, Mar. 27, 1981]

Source:21 CFR 74.2261 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 11

D&C Orange No. 11. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b) of this chapter. D&C Orange No. 11 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981]

Conditions: D&C Orange No. 11. The color additive D&C Orange No. 11 shall conform in identity and specifications to the requirements of § 74.1261(a)(1) and (b) of this chapter. D&C Orange No. 11 is restricted to use in externally applied drugs and cosmetics. [46 FR 18954, Mar. 27, 1981]

Source:21 CFR 82.1261 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 4

D&C Orange No. 4. (a) Identity and specifications. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254 (a)(1) and (b). (b) Uses and restrictions. D&C Orange 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 D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 52396, Sept. 30, 1977]

Conditions: D&C Orange No. 4. (a) Identity and specifications. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254 (a)(1) and (b). (b) Uses and restrictions. D&C Orange 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 D&C Orange No. 4 shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 52396, Sept. 30, 1977]

Source:21 CFR 74.2254 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 4

D&C Orange No. 4. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254(a)(1) and (b) of this chapter. D&C Orange No. 4 is restricted to use in externally applied drugs and cosmetics. [42 FR 52396, Sept. 30, 1977]

Conditions: D&C Orange No. 4. The color additive D&C Orange No. 4 shall conform in identity and specifications to the requirements of § 74.1254(a)(1) and (b) of this chapter. D&C Orange No. 4 is restricted to use in externally applied drugs and cosmetics. [42 FR 52396, Sept. 30, 1977]

Source:21 CFR 82.1254 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 5

D&C Orange No. 5. (a) Identity and specifications. The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255 (a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested cosmetics in amounts consistent with current good manufacturing practice. D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products. D&C Orange No. 5 may be safely used for coloring externally applied cosmetics 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 Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]

Conditions: D&C Orange No. 5. (a) Identity and specifications. The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255 (a)(1) and (b). (b) Uses and restrictions. D&C Orange No. 5 may be safely used for coloring mouthwashes and dentifrices that are ingested cosmetics in amounts consistent with current good manufacturing practice. D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products. D&C Orange No. 5 may be safely used for coloring externally applied cosmetics 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 Orange No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984]

Source:21 CFR 74.2255 · version 2026-08-27 · source checked 2026-08-30

D&C Orange No. 5

D&C Orange No. 5. (a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255(a)(1) and (b) of this chapter. D&C Orange No. 5 is restricted to the uses described in this section. (b) The color additive D&C Orange No. 5. may be safely used for coloring externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. The color additive D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products, and for coloring mouthwashes, dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice. [49 FR 13343, Apr. 4, 1984]

Conditions: D&C Orange No. 5. (a) The color additive D&C Orange No. 5 shall conform in identity and specifications to the requirements of § 74.1255(a)(1) and (b) of this chapter. D&C Orange No. 5 is restricted to the uses described in this section. (b) The color additive D&C Orange No. 5. may be safely used for coloring externally applied drugs in amounts not exceeding 5 milligrams per daily dose of the drug. The color additive D&C Orange No. 5 may be safely used for coloring lipsticks and other cosmetics intended to be applied to the lips in amounts not exceeding 5.0 percent by weight of the finished cosmetic products, and for coloring mouthwashes, dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice. [49 FR 13343, Apr. 4, 1984]

Source:21 CFR 82.1255 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 17

D&C Red No. 17. (a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 17 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 Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Red No. 17. (a) Identity and specifications. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 17 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 Red No. 17 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2317 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 17

D&C Red No. 17. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317 (a)(1) and (b) of this chapter. D&C Red No. 17 is restricted to use in externally applied drugs and cosmetics.

Conditions: D&C Red No. 17. The color additive D&C Red No. 17 shall conform in identity and specifications to the requirements of § 74.1317 (a)(1) and (b) of this chapter. D&C Red No. 17 is restricted to use in externally applied drugs and cosmetics.

Source:21 CFR 82.1317 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 21

D&C Red No. 21. (a) Identity and specifications. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 21 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. 21 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982]

Conditions: D&C Red No. 21. (a) Identity and specifications. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 21 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. 21 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982]

Source:21 CFR 74.2321 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 21

D&C Red No. 21. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982]

Conditions: D&C Red No. 21. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of § 74.1321 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982]

Source:21 CFR 82.1321 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 22

D&C Red No. 22. (a) Identity and specifications. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 22 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. 22 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982]

Conditions: D&C Red No. 22. (a) Identity and specifications. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 22 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. 22 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 53846, Nov. 30, 1982]

Source:21 CFR 74.2322 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 22

D&C Red No. 22. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982]

Conditions: D&C Red No. 22. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of § 74.1322 (a)(1) and (b) of this chapter. [47 FR 53847, Nov. 30, 1982]

Source:21 CFR 82.1322 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 27

D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 27 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. 27 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982]

Conditions: D&C Red No. 27. (a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 27 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. 27 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982]

Source:21 CFR 74.2327 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 27

D&C Red No. 27. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982]

Conditions: D&C Red No. 27. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of § 74.1327 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982]

Source:21 CFR 82.1327 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 28

D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 28 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. 28 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982]

Conditions: D&C Red No. 28. (a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 28 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. 28 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 42568, Sept. 28, 1982]

Source:21 CFR 74.2328 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 28

D&C Red No. 28. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982]

Conditions: D&C Red No. 28. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of § 74.1328 (a)(1) and (b) of this chapter. [47 FR 42568, Sept. 28, 1982]

Source:21 CFR 82.1328 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 30

D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 30 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. 30 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 22511, May 25, 1982]

Conditions: D&C Red No. 30. (a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 30 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. 30 shall be certified in accordance with regulations in part 80 of this chapter. [47 FR 22511, May 25, 1982]

Source:21 CFR 74.2330 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 30

D&C Red No. 30. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b) of this chapter. [47 FR 22511, May 25, 1982]

Conditions: D&C Red No. 30. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of § 74.1330 (a)(1) and (b) of this chapter. [47 FR 22511, May 25, 1982]

Source:21 CFR 82.1330 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 31

D&C Red No. 31. (a) Identity and specifications. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 31 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 Red No. 31 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Red No. 31. (a) Identity and specifications. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 31 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 Red No. 31 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2331 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 31

D&C Red No. 31. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b) of this chapter. D&C Red No. 31 is restricted to use in externally applied drugs and cosmetics.

Conditions: D&C Red No. 31. The color additive D&C Red No. 31 shall conform in identity and specifications to the requirements of § 74.1331(a)(1) and (b) of this chapter. D&C Red No. 31 is restricted to use in externally applied drugs and cosmetics.

Source:21 CFR 82.1331 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 33

D&C Red No. 33. (a) Identity and specifications. The color additive D&C Red No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 33 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresheners), dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice. (c) Labeling requirements. 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. (d) Certification. All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 33120, Aug. 30, 1988]

Conditions: D&C Red No. 33. (a) Identity and specifications. The color additive D&C Red No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 33 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 33 may be safely used for coloring mouthwashes (including breath fresheners), dentifrices, and externally applied cosmetics in amounts consistent with current good manufacturing practice. (c) Labeling requirements. 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. (d) Certification. All batches of D&C Red No. 33 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 33120, Aug. 30, 1988]

Source:21 CFR 74.2333 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 33

D&C Red No. 33. (a) The color additive D&C Red. No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b) of this chapter. (b) All lakes of D&C Red. No. 33 shall be manufactured from previously certified batches of the straight color additive. [53 FR 33121, Aug. 30, 1988]

Conditions: D&C Red No. 33. (a) The color additive D&C Red. No. 33 shall conform in identity and specifications to the requirements of § 74.1333(a) (1) and (b) of this chapter. (b) All lakes of D&C Red. No. 33 shall be manufactured from previously certified batches of the straight color additive. [53 FR 33121, Aug. 30, 1988]

Source:21 CFR 82.1333 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 34

D&C Red No. 34. (a) Identity and specifications. The color additive D&C Red No. 34 shall conform in identity and specifications to the requirements of § 74.1334(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 34 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 Red No. 34 shall be certified in accordance with regulations in part 80 of this chapter.

Conditions: D&C Red No. 34. (a) Identity and specifications. The color additive D&C Red No. 34 shall conform in identity and specifications to the requirements of § 74.1334(a)(1) and (b). (b) Uses and restrictions. D&C Red No. 34 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 Red No. 34 shall be certified in accordance with regulations in part 80 of this chapter.

Source:21 CFR 74.2334 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 34

D&C Red No. 34. Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naphthalenyl)azol-2-naphthalenecarboxylic acid. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Total color not less than 85 percent.

Conditions: D&C Red No. 34. Calcium salt of 3-hydroxy-4-[(1-sulfo-2 -naphthalenyl)azol-2-naphthalenecarboxylic acid. Sum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent. 2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthoic acid, not more than 0.4 percent. Subsidiary colors, not more than 4 percent. Total color not less than 85 percent.

Source:21 CFR 82.1334 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 36

D&C Red No. 36. (a) Identity and specifications. The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 36 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 36 may be safely used for coloring externally applied cosmetics 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. 36 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 29031, Aug. 2, 1988]

Conditions: D&C Red No. 36. (a) Identity and specifications. The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 36 may be safely used for coloring cosmetic lip products in amounts not to exceed 3 percent total color by weight of the finished cosmetic products. D&C Red No. 36 may be safely used for coloring externally applied cosmetics 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. 36 shall be certified in accordance with regulations in part 80 of this chapter. [53 FR 29031, Aug. 2, 1988]

Source:21 CFR 74.2336 · version 2026-08-27 · source checked 2026-08-30

D&C Red No. 36

D&C Red No. 36. (a) The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b) of this chapter. (b) All lakes of D&C Red No. 36 shall be manufactured from previously certified batches of the straight color additive. [53 FR 29031, Aug. 2, 1988]

Conditions: D&C Red No. 36. (a) The color additive D&C Red No. 36 shall conform in identity and specifications to the requirements of § 74.1336 (a)(1) and (b) of this chapter. (b) All lakes of D&C Red No. 36 shall be manufactured from previously certified batches of the straight color additive. [53 FR 29031, Aug. 2, 1988]

Source:21 CFR 82.1336 · version 2026-08-27 · source checked 2026-08-30