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Guidance, Compliance & Regulatory Information
Voluntary Cosmetic Registration Program (VCRP)
Online Registration- Color Additives Permitted for Use in Cosmetics: Table
April 30, 2008; Updated June 20, 2008 and February 22, 2010
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 Devices1. 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), Subpart C of Part 73 (Listing of Color Additives Exempt from Certification), Subpart C of Part 74 (Listing of Color Additives Subject to Certification), and Subparts C and D of Part 82 (Listing of Certified Provisionally Listed Colors and Specifications). 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 Cosmetics2.
Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics
(21 CFR Part 73 Subpart C—Cosmetics3) Color Additive Eye Area Generally
(Includes
Lipsticks) External Use Specific Limitations
and Comments 21 CFR
Section
Aluminum powder Yes No Yes 73.26454
Annatto Yes Yes Yes 73.20305
Bismuth citrate No No Subject to limitations Hair on the scalp 73.21106
Bismuth oxychloride Yes Yes Yes 73.21627
Bronze powder Yes Yes Yes 73.26468
Caramel Yes Yes Yes 73.20859
Carmine Yes Yes Yes 73.208710
β-Carotene Yes Yes Yes 73.209511
Chromium hydroxide green Yes No Yes 73.232612
Chromium oxide greens Yes No Yes 73.232713
Copper powder Yes Yes Yes 73.264714
Dihydroxyacetone No No Subject to limitations For use in tanning preparations 73.215015
Disodium EDTA-copper No No Subject to limitations Shampoos 73.212016
Ferric ammonium ferrocyanide Yes No Yes 73.229817
Ferric ferrocyanide Yes No Yes 73.229918
Guaiazulene No No Yes 73.218019
Guanine Yes Yes Yes 73.232920
Henna No No Subject to limitations Hair on the scalp 73.219021
Iron oxides Yes Yes Yes 73.225022
Lead acetate No No Subject to limitations Hair on the scalp; ≤0.6% lead 73.239623
Luminescent zinc sulfide No No Subject to limitations Externally applied facial makeup and nail polish; <10%; for infrequent use (e.g., Halloween) 73.299524
Manganese violet Yes Yes Yes 73.277525
Mica Yes Yes Yes 73.249626
Potassium sodium copper chlorophyllin (chlorophyllin-copper complex) No No Subject to limitations Dentifrices; ≤0.1% 73.212527
Pyrophyllite No No Yes 73.240028
Silver No No Subject to limitations Fingernail polish; ≤1% 73.250029
Titanium dioxide Yes Yes Yes 73.257530
Ultramarines Yes No Yes 73.272531
Zinc oxide Yes Yes Yes 73.299132
--------------------------------------------------------------------------------
Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics*
Includes Straight Colors and Lakes
(21 CFR Part 74 Subpart C—Cosmetics33, and 21 CFR Part 82 Subpart C--Drugs and Cosmetics34 and Subpart D--Externally Applied Drugs and Cosmetics35) 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, blushers & rouge, makeup & foundation, nail enamel 74.205236
D&C Black No. 3 Subject to Limitations No Subject to Limitations Eyeliner, eye shadow, mascara, face powder 74.205337
FD&C Blue No. 1 Yes, also Al lake Yes Yes 74.210138
D&C Blue No. 4 No No Yes 74.210439
D&C Brown No. 1 No No Yes 74.215140
FD&C Green No. 3 No Yes Yes 74.220341
D&C Green No. 5 Yes Yes Yes 74.220542
D&C Green No. 6 No No Yes 74.220643
D&C Green No. 8 No No Subject to Limitations ≤0.01% 74.220844
D&C Orange No. 4 No No Yes 74.225445
D&C Orange No. 5 No Subject to Limitations Yes Mouthwashes, dentifrices; ≤5% for lipsticks 74.225546
D&C Orange No. 10 No No Yes 74.226047
D&C Orange No. 11 No No Yes 74.226148
FD&C Red No. 4 No No Yes 74.230449
D&C Red No. 6 No Yes Yes 74.230650
D&C Red No. 7 No Yes Yes 74.230751
D&C Red No. 17 No No Yes 74.231752
D&C Red No. 21 No Yes Yes 74.232153
D&C Red No. 22 No Yes Yes 74.232254
D&C Red No. 27 No Yes Yes 74.232755
D&C Red No. 28 No Yes Yes 74.232856
D&C Red No. 30 No Yes Yes 74.233057
D&C Red No. 31 No No Yes 74.233158
D&C Red No. 33 No Subject to Limitations Yes Lipstick products ≤3%; mouthwash, dentrifices 74.233359
D&C Red No. 34 No No Yes 74.233460
D&C Red No. 36 No Subject to Limitations Yes Lipstick products ≤3% 74.233661
FD&C Red No. 40 Yes, also Al lake Yes Yes 74.234062
D&C Violet No. 2 No No Yes 74.260263
Ext. D&C Violet No. 2 No No Yes 74.2602a64
FD&C Yellow No. 5 Yes, also Al lake Yes Yes 74.270565
FD&C Yellow No. 6 No Yes Yes 74.270666
D&C Yellow No. 7 No No Yes 74.270767
Ext. D&C Yellow No. 7 No No Yes 74.2707a68
D&C Yellow No. 8 No No Yes 74.270869
D&C Yellow No. 10 No Yes Yes 74.271070
D&C Yellow No. 11 No No Yes 74.271171
*Includes straight colors and lakes
**Excludes lakes except where noted. Only aluminum lakes on alumina are permitted for designated lakes.
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