Colour Additives
Color Additives Approved for Use in CosmeticsPart 73, Subpart C: Color additives exempt from batch certification |
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| 21 CFR Section | Straight Color | Year (2)Approved | Uses and Restrictions |
| 73.2030 | Annatto | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2085 | Caramel | 1981 | Cosmetics generally (5) including eye area use. |
| 73.2087 | Carmine | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2095 | β-Carotene | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2110 | Bismuth citrate(3) | 1978 | Cosmetics intended for coloring hair on the scalp only NTE (7) 0.5 percent. |
| 73.2120 | Disodium EDTA-copper | 1974 | Coloring of shampoos that are cosmetics. |
| 73.2125 | Potassium sodium copper chlorophyllin (chlorophyllin copper-complex) | 1969 | Coloring dentifrices that are cosmetics NTE (7) 0.1% in combination with a list of substances. |
| 73.2150 | Dihydroxyacetone | 1973 | Externally applied cosmetics (6) intended solely or in part to impart color to the human body. |
| 73.2162 | Bismuth oxychloride | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2180 | Guaiazulene | 1977 | Externally applied cosmetics (6). |
| 73.2190 | Henna(3) | 1965 | Coloring hair but not eyelashes, eyebrows, or eye area. |
| 73.2250 | Iron oxides | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2298 | Ferric ammonium ferrocyanide | 1977 | Externally applied cosmetics (6) including eye area use. |
| 73.2299 | Ferric ferrocyanide | 1978 | Externally applied cosmetics(6) including eye area use. |
| 73.2326 | Chromium hydroxide green | 1977 | Externally applied cosmetics(6) including eye area use. |
| 73.2327 | Chromium oxide greens | 1977 | Externally applied cosmetics (6) including eye area use. |
| 73.2329 | Guanine | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2396 | Lead acetate(3) | 1981 | Cosmetics intended for coloring hair on the scalp only, NTE (7) 0.6 percent Pb (weight/volume). |
| 73.2400 | Pyrophyllite | 1973 | Externally applied cosmetics (6). |
| 73.2496 | Mica | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2500 | Silver (3) | 1979 | Coloring fingernail polish NTE (7) 1% of final product. |
| 73.2575 | Titanium dioxide | 1973 | Cosmetics including eye area use. |
| 73.2645 | Aluminum powder | 1977 | Externally applied cosmetics (6) including eye area use. |
| 73.2646 | Bronze powder | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2647 | Copper powder | 1977 | Cosmetics generally (5) including eye area use. |
| 73.2725 | Ultramarines | 1976 | Externally applied cosmetics (6) including eye area use. |
| 73.2775 | Manganese violet | 1976 | Cosmetics generally (5) including eye area use. |
| 73.2991 | Zinc oxide | 1977 | Cosmetics including eye area use. |
| 73.2995 | Luminescent zinc sulfide (3) | 2000 | Nail polish and externally applied facial makeup (6) NTE (7) 10% of final product for limited, occasional use. |
Color Additives Approved for Use in CosmeticsPart 74, Subpart C: Color additives subject to batch certification |
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| 21 CFR Section | Straight Color | Year (2)Approved | Uses and Restrictions |
| 74.2052 | D&C Black No. 2 (3) | 2004 | Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel. |
| 74.2101 | FD&C Blue No. 1 | 1982 | Cosmetics generally (5). |
| 1993 | Allows MnO2 in manufacture. | ||
| 1994 | Eye area use (includes lake). | ||
| 74.2104 | D&C Blue No. 4 | 1977 | Externally applied cosmetics (6) . |
| 74.2151 | D&C Brown No. 1 | 1976 | Externally applied cosmetics (6) . |
| 74.2203 | FD&C Green No. 3 | 1982 | Cosmetics generally (5). |
| 74.2205 | D&C Green No. 5 | 1982 | Cosmetics generally (5). |
| 1994 | Eye area use. | ||
| 74.2206 | D&C Green No. 6 | 1982 | Externally applied cosmetics (6) . |
| 74.2208 | D&C Green No. 8 | 1976 | Externally applied cosmetics (6) (NTE) (7) 0.01% (by wt) of finished cosmetic product). |
| 74.2254 | D&C Orange No. 4 | 1977 | Externally applied cosmetics (6) . |
| 74.2255 | D&C Orange No. 5 | 1984 | Externally applied cosmetics (6) . |
| 1982 | Mouthwashes, dentifrices, lipsticks, and other lip cosmetics NTE (7) 5 percent. | ||
| 74.2260 | D&C Orange No. 10 | 1981 | Externally applied cosmetics (6) . |
| 74.2261 | D&C Orange No. 11 | 1981 | Externally applied cosmetics (6) . |
| 74.2304 | FD&C Red No. 4 | 1976 | Externally applied cosmetics (6) . |
| 74.2306 | D&C Red No. 6 | 1983 | Cosmetics generally (5). |
| 74.2307 | D&C Red No. 7 | 1983 | Cosmetics generally (5). |
| 74.2317 | D&C Red No. 17 | 1976 | Externally applied cosmetics (6) . |
| 74.2321 | D&C Red No. 21 | 1982 | Cosmetics generally (5). |
| 74.2322 | D&C Red No. 22 | 1982 | Cosmetics generally (5). |
| 74.2327 | D&C Red No. 27 | 1982 | Cosmetics generally (5). |
| 74.2328 | D&C Red No. 28 | 1982 | Cosmetics generally (5). |
| 74.2330 | D&C Red No. 30 | 1982 | Cosmetics generally (5). |
| 74.2331 | D&C Red No. 31 | 1976 | Externally applied cosmetics (6) . |
| 74.2333 | D&C Red No. 33 | 1988 | Externally applied cosmetics (6) ; mouthwashes, dentifrices; cosmetic lip products (NTE) (7) 3% (by wt) of finished cosmetic product). |
| 74.2334 | D&C Red No. 34 | 1976 | Externally applied cosmetics (6) . |
| 74.2336 | D&C Red No. 36 | 1988 | Externally applied cosmetics (6); cosmetic lip products (NTE) (7) 3% (by wt) of finished cosmetic product). |
| 74.2340 | FD&C Red No. 40(3) | 1975 | Cosmetics generally (5). |
| 1994 | Eye area use (includes Al lake). No oxidizing or reducing agents that may affect integrity. | ||
| 74.2602 | D&C Violet No. 2 | 1976 | Externally applied cosmetics (6) . |
| 74.2602a | Ext. D&C Violet No. 2 | 1976 | Externally applied cosmetics (6) . |
| 74.2705 | FD&C Yellow No. 5 | 1985 | Cosmetics generally (5). |
| 1994 | Eye area use (includes Al lake). | ||
| 74.2706 | FD&C Yellow No. 6 | 1986 | Cosmetics generally (5). |
| 74.2707 | D&C Yellow No. 7 | 1976 | Externally applied cosmetics (6). |
| 74.2707a | Ext. D&C Yellow No. 7 | 1976 | Externally applied cosmetics (6). |
| 74.2708 | D&C Yellow No. 8 | 1976 | Externally applied cosmetics (6). |
| 74.2710 | D&C Yellow No. 10 | 1983 | Cosmetics generally (5). |
| 1984 | Modification of uses and restrictions. | ||
| 74.2711 | D&C Yellow No. 11 | 1976 | Externally applied cosmetics (6). |
CFSAN/Office of Cosmetics and Colors, Center for Food Safety & Applied Nutrition Department of Health & Human Services, U.S. Food & Drug Administration. January 24, 2006; Revised April 20, 2007.