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Cosmetics

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Color Additives Permitted for Use in Cosmetics

April 30, 2008; Updated June 20, 2008

The tables below are provided as a supplement to the information in the Summary of Color Additives Listed for Use in the United States in Food, Drugs, Cosmetics, and Medical Devices. They are intended for quick reference to help in determining which color additives may be used in different types of cosmetics, as provided for in Title 21 of the Code of Federal Regulations (CFR), Subparts C of Part 73 (Listing of Color Additives Exempt from Certification) and of Part 74 (Listing of Color Additives Subject to Certification). For additional information on the permitted use, specifications, and restrictions that apply to each color additive, please refer to the appropriate listing regulation, using the links provided in the tables. For more information on the use of color additives in cosmetics in general, please see Color Additives and Cosmetics.

Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics
(21 CFR Part 73 Subpart C—Cosmetics)
Color Additive Eye Area Generally
(Includes
Lipsticks)
External Use Specific Limitations
and Comments
21 CFR
Section
Aluminum powder Yes No Yes   73.2645
Annatto Yes Yes Yes   73.2030
Bismuth citrate No No No Hair on the scalp 73.2110
Bismuth oxychloride Yes Yes Yes   73.2162
Bronze powder Yes Yes Yes   73.2646
Caramel Yes Yes Yes   73.2085
Carmine Yes Yes Yes   73.2087
β-Carotene Yes Yes Yes   73.2095
Chromium hydroxide green Yes No Yes   73.2326
Chromium oxide greens Yes No Yes   73.2327
Copper powder Yes Yes Yes   73.2647
Dihydroxyacetone No No No Externally applied cosmetics to color the body 73.2150
Disodium EDTA-copper No No No Shampoos 73.2120
Ferric ammonium ferrocyanide Yes No Yes   73.2298
Ferric ferrocyanide Yes No Yes   73.2299
Guaiazulene No No Yes   73.2180
Guanine Yes Yes Yes   73.2329
Henna No No No Hair on the scalp 73.2190
Iron oxides Yes Yes Yes   73.2250
Lead acetate No No No Hair on the scalp; ≤ 0.6% 73.2396
Luminescent zinc sulfide No No No Externally applied facial makeup and nail polish; < 10%; for infrequent use (Halloween) 73.2995
Manganese violet Yes Yes Yes   73.2775
Mica Yes Yes Yes   73.2496
Potassium sodium copper chlorophyllin;
Chlorophyllin-copper complex
No No No Dentifrices; ≤ 0.1% 73.2125
Pyrophyllite No No Yes   73.2400
Silver No No No Fingernail polish; ≤ 1% 73.2500
Titanium dioxide Yes Yes Yes   73.2575
Ultramarines Yes No Yes   73.2725
Zinc oxide Yes Yes Yes   73.2991

 


 

Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics
(21 CFR Part 74 Subpart C—Cosmetics)
Color Additive Eye Area* Generally
(Includes
Lipsticks)
External Use Specific Limitations
and Comments
21 CFR
Section
D&C Black No. 2 Subject to Limitations Subject to Limitations Subject to Limitations Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blusher & rouge, makeup & foundation, nail enamel 74.2052
D&C Black No. 3 Subject to Limitations No Subject to Limitations Eyeliner, eye shadow, mascara, face powder 74.2053
FD&C Blue No. 1 Yes (Al lake) Yes Yes   74.2101
D&C Blue No. 4 No No Yes   74.2104
D&C Brown No. 1 No No Yes   74.2151
FD&C Green No. 3 No Yes Yes   74.2203
D&C Green No. 5 Yes Yes Yes   74.2205
D&C Green No. 6 No No Yes   74.2206
D&C Green No. 8 No No Subject to Limitations ≤ 0.01% 74.2208
D&C Orange No. 4 No No Yes   74.2254
D&C Orange No. 5 No Subject to Limitations Yes Mouthwashes, dentifrices; ≤ 5% for lipsticks 74.2255
D&C Orange No. 10 No No Yes   74.2260
D&C Orange No. 11 No No Yes   74.2261
FD&C Red No. 4 No No Yes   74.2304
D&C Red No. 6 No Yes Yes   74.2306
D&C Red No. 7 No Yes Yes   74.2307
D&C Red No. 17 No No Yes   74.2317
D&C Red No. 21 No Yes Yes   74.2321
D&C Red No. 22 No Yes Yes   74.2322
D&C Red No. 27 No Yes Yes   74.2327
D&C Red No. 28 No Yes Yes   74.2328
D&C Red No. 30 No Yes Yes   74.2330
D&C Red No. 31 No No Yes   74.2331
D&C Red No. 33 No Subject to Limitations Yes Lipstick products ≤ 3%; mouthwash, dentrifices 74.2333
D&C Red No. 34 No No Yes   74.2334
D&C Red No. 36 No Subject to Limitations Yes Lipstick products ≤ 3% 74.2336
FD&C Red No. 40 Yes (Al lake) Yes Yes   74.2340
D&C Violet No. 2 No No Yes   74.2602
Ext. D&C Violet No. 2 No No Yes   74.2602a
FD&C Yellow No. 5 Yes (Al lake) Yes Yes   74.2705
FD&C Yellow No. 6 No Yes Yes   74.2706
D&C Yellow No. 7 No No Yes   74.2707
Ext. D&C Yellow No. 7 No No Yes   74.2707a
D&C Yellow No. 8 No No Yes   74.2708
D&C Yellow No. 10 No Yes Yes   74.2710
D&C Yellow No. 11 No No Yes   74.2711

*Note: Excludes lakes except where noted. Only aluminum lakes on alumina are permitted for designated lakes.

    
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