最新|美国化妆品的允许使用色素添加剂(2022版)

美国OTC/NDC 李锦聪 52
妆企易团队

免于认证并允许用于化妆品的色素添加剂(21 CFR 第 73 部分 C 子部分 - 化妆品)

Color AdditiveEye AreaGenerally
(Includes
Lipsticks)
External UseSpecific Limitations
and Comments
21 CFR
Section
Aluminum powderYesNoYes 73.2645
AnnattoYesYesYes 73.2030
Bismuth citrateNoNoSubject to limitationsHair on the scalp73.2110
Bismuth oxychlorideYesYesYes 73.2162
Bronze powderYesYesYes 73.2646
CaramelYesYesYes 73.2085
CarmineYesYesYes 73.2087
β-CaroteneYesYesYes 73.2095
Chromium
hydroxide green
YesNoYes 73.2326
Chromium oxide greensYesNoYes 73.2327
Copper powderYesYesYes 73.2647
DihydroxyacetoneNoNoSubject to limitationsFor use in tanning preparations73.2150
Disodium
EDTA-copper
NoNoSubject to limitationsShampoos73.2120
Ferric ammonium
ferrocyanide
YesNoYes 73.2298
Ferric ferrocyanideYesNoYes 73.2299
GuaiazuleneNoNoYes 73.2180
GuanineYesYesYes 73.2329
HennaNoNoSubject to limitationsHair on the scalp73.2190
Iron oxidesYesYesYes 73.2250
Luminescent
zinc sulfide
NoNoSubject to limitationsExternally applied facial makeup and nail polish; <10%; for="" infrequent="" use="" (e.g.,="">73.2995
Manganese violetYesYesYes 73.2775
MicaYesYesYes 73.2496
Potassium sodium
copper chlorophyllin
(chlorophyllin-copper
complex)
NoNoSubject to limitationsDentifrices; ≤0.1%73.2125
PyrophylliteNoNoYes 73.2400
SilverNoNoSubject to limitationsFingernail polish; ≤1%73.2500
Silver nitrateYesNoNoExternally applied professional-use only cosmetics intended to impart color to the eyebrows and eyelashes, NTE 4% by weight, additional restrictions73.2550
Titanium dioxideYesYesYes 73.2575
UltramarinesYesNoYes 73.2725
Zinc oxideYesYesYes 73.2991


需要认证并允许用于化妆品*的色素添加剂包括纯色和色淀(21 CFR 第 74 部分 C 子部分 - 化妆品和 21 CFR 第 82 部分 B、C 和 D 子部分)

Color AdditiveEye Area**Generally
(Includes
Lipsticks)
External UseSpecific Limitations
and Comments
21 CFR
Section
D&C Black No. 2Subject to LimitationsSubject to LimitationsSubject to LimitationsEyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers & rouge, makeup & foundation, nail enamel74.2052
D&C Black No. 3Subject to LimitationsNoSubject to LimitationsEyeliner, eye shadow, mascara, face powder74.2053
FD&C Blue No. 1Yes, also Al lakeYesYes 74.2101
D&C Blue No. 4NoNoYes 74.2104
D&C Brown No. 1NoNoYes 74.2151
FD&C Green No. 3NoYesYes 74.2203
D&C Green No. 5YesYesYes 74.2205
D&C Green No. 6NoNoYes 74.2206
D&C Green No. 8NoNoSubject to Limitations≤0.01%74.2208
D&C Orange No. 4NoNoYes 74.2254
D&C Orange No. 5NoSubject to LimitationsYesMouthwashes, dentifrices; ≤5% for lipsticks74.2255
D&C Orange No. 10NoNoYes 74.2260
D&C Orange No. 11NoNoYes 74.2261
FD&C Red No. 4NoNoYes 74.2304
D&C Red No. 6NoYesYes 74.2306
D&C Red No. 7NoYesYes 74.2307
D&C Red No. 17NoNoYes 74.2317
D&C Red No. 21NoYesYes 74.2321
D&C Red No. 22NoYesYes 74.2322
D&C Red No. 27NoYesYes 74.2327
D&C Red No. 28NoYesYes 74.2328
D&C Red No. 30NoYesYes 74.2330
D&C Red No. 31NoNoYes 74.2331
D&C Red No. 33NoSubject to LimitationsYesLipstick
products ≤3%; mouthwash, dentrifices
74.2333
D&C Red No. 34NoNoYes 74.2334
D&C Red No. 36NoSubject to LimitationsYesLipstick
products ≤3%
74.2336
FD&C Red No. 40Yes, also Al lakeYesYes 74.2340
D&C Violet No. 2NoNoYes 74.2602
Ext. D&C Violet No. 2NoNoYes 74.2602a
FD&C Yellow No. 5Yes, also Al lakeYesYes 74.2705
FD&C Yellow No. 6NoYesYes 74.2706
D&C Yellow No. 7NoNoYes 74.2707
Ext. D&C
Yellow No. 7
NoNoYes 74.2707a
D&C Yellow No. 8NoNoYes 74.2708
D&C Yellow No. 10NoYesYes 74.2710
D&C Yellow No. 11NoNoYes 74.2711


*Includes straight colors and lakes

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


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