FDA facts sheet #5
Text copied directly from the FDA web site http://vm.cfsan.fda.gov/~dms/cos-hdb4.html
Color Additive Cosmetic Use* 21 CFR
FD&C Blue No. 1 Generally, including cosmetics 74.2101
(including the intended for use in the area of the eye
Aluminum Lake)
FD&C Green No. 3 Except eye area 74.2203
FD&C Red No. 4 Externally except eye area 74.2304
FD&C Red No. 40 Generally, including cosmetics 74.2340
(including the intended for use in the area of the eye
Aluminum Lake)
FD&C Yellow No. 5 Except eye area 74.2705
FD&C Yellow No. 6 Except eye area 74.2706
D&C Blue No. 4 Externally except eye area 74.2104
D&C Brown No. 1 Externally except eye area 74.2151
D&C Green No. 5 Generally, including cosmetics
intended for use in the area of the eye
D&C Green No. 6 Externally except eye area 74.2206
D&C Green No. 8 Externally except eye area(0.01%maximum) 74.2208
D&C Orange No. 4 Externally except eye area 74.2254
D&C Orange No. 5 Externally except eye area 74.2255
Lip products (5% maximum)
Mouthwashes/dentifrices (GMP)
D&C Orange No. 10 Externally except eye area 74.2260
D&C Orange No. 11 Externally except eye area 74.2261
D&C Red No. 6 Except eye area 74.2306
D&C Red No. 7 Except eye area 74.2307
D&C Red No. 17 Externally except eye area 74.2317
D&C Red No. 21 Except eye area 74.2321
D&C Red No. 22 Except eye area 74.2322
D&C Red No. 27 Except eye area 74.2327
D&C Red No. 28 Except eye area 74.2328
D&C Red No. 30 Except eye area 74.2330
D&C Red No. 31 Externally except eye area 74.2331
D&C Red No. 33 Externally except eye area 74.2333
Lip products (3% maximum)
Mouthwashes/dentifrices (GMP)
D&C Red No. 34 Externally except eye area 74.2334
D&C Red No. 36 Externally except eye area 74.2336
Lip products (3% maximum)
D&C Violet No. 2 Externally except eye area 74.2602
D&C Yellow No. 7 Externally except eye area 74.2707
D&C Yellow No. 8 Externally except eye area 74.2708
D&C Yellow No. 10 Except eye area 74.2710
D&C Yellow No. 11 Externally except eye area 74.2711
Ext.D&C Violet No. 2 Externally except eye area 74.2602a
Ext.D&C Yellow No. 7 Externally except eye area 74.2707a
* As a general rule, color additives should not be exposed to oxidizing or reducing agents that may affect the integrity of the color additives. Amounts of color additives used in cosmetic products are restricted to levels consistent with good manufacturing practice (unless the regulation specifies a maximum level).
Color Additive Cosmetic Use 21 CFR
Lakes of As specified in listing of 82.1051
FD&C Blue No. 1 straight color in Part 74
FD&C Green No. 3
FD&C Red No. 4
FD&C Yellow No. 5
FD&C Yellow No. 6
D&C Blue No.4
D&C Green No. 5
D&C Green No. 6
D&C Orange No. 4
D&C Orange No. 5
D&C Orange No. 10
D&C Orange No. 11
D&C Red No. 6
D&C Red No. 7
D&C Red No. 17
D&C Red No. 21
D&C Red No. 22
D&C Red No. 27
D&C Red No. 28
D&C Red No. 30
D&C Red No. 31
D&C Red No. 33
D&C Red No. 34
D&C Red No. 36
D&C Violet No. 2
D&C Yellow No. 7
D&C Yellow No. 8
D&C Yellow No. 10
Lakes of
Ext. D&C Yellow No. 7 Externally except 82.2051
in eye area
Color Additive Cosmetic Use 21 CFR
Aluminum powder Externally including eye area 73.2645
Annatto No restrictions 73.2030
Bismuth citrate Scalp hair dye only
(0.5% w/v maximum) 73.2110
Bismuth oxychloride No restrictions 73.2162
Bronze powder No restrictions 73.2646
Caramel No restrictions 73.2085
Carmine No restrictions 73.2087
Carotene, Beta- No restrictions 73.2095
Chromium hydroxide green Externally including eye area 73.2326
Chromium oxide greens Externally including eye area 73.2327
Copper powder No restrictions 73.2647
Dihydroxyacetone Externally except eye area
(only for imparting color to
human body) 73.2150
Disodium EDTA-copper Cosmetic shampoo only 73.2120
Ferric ammonium
ferrocyanide Externally including eye area 73.2298
Ferric ferrocyanide Externally including eye area 73.2299
Guanine No restrictions 73.2329
Guaiazulene Externally except eye area 73.2180
Henna Scalp hair dye only 73.2190
Iron oxides No restrictions 73.2250
Lead acetate Scalp hair dye only 73.2396
(0.6% Pb w/v maximum)
Manganese violet No restrictions 73.2775
Mica No restrictions 73.2496
Potassium sodium Cosmetic dentifrices 73.2125
copper chlorophyllin (0.1% maximum)
(chlorophyllin-copper (required combination with
complex) specified substances
Pyrophyllite Externally except eye area 73.2400
Silver Nail polish only (1% maximum) 73.2500
Titanium dioxide No restrictions 73.2575
Ultramarines (blue, green, Externally including eye area 73.2725
pink, red, violet)
Zinc oxide No restrictions 73.2991
*FDA/Industry Activities Staff Booklet: 1992
Code of Federal Regulations relating to Cosmetic Products
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