Colors in Cosmetics: Regulation and

Nomenclature in the United States

In the United States, with the exception of one class of hair dyes, all color additives for cosmetics must be

specifically pre-approved for use by the Food and Drug Administration. A law that governs cosmetics, the

Federal Food, Drug, and Cosmetic Act, requires that FDA issue a specific regulation for each color

additive which prescribes its conditions of use and the specifications for its safe use

(http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.

htm). In addition, batch certification (testing by FDA) is required for most color additives to assure that they

meet the specifications of the regulations. Use of an unapproved color additive in a cosmetic product, or of

an approved color additive, but in an unapproved manner, makes the product illegal, adulterated and

subject to seizure by FDA

(http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.

htm).

The official names for color additives in the U.S. are designated by FDA. Colors subject to batch

certification are designated as FD&C (food, drug, and cosmetics), D&C (drug and cosmetics), or Ext. D&C

(external drugs and cosmetics). This is followed by a color designation, such as blue or red, and by No.

(for number), and by a numeral. An example of such a name is FD&C Red No. 40. Colors made by

combining these "straight" colors with "substrates" (sodium, potassium, aluminum, barium, calcium

strontium, or zirconium) are known as "lakes" and are named using the same convention, but with the

addition of the word lake and the substrate, for example: FD&C Red No. 40 Aluminum Lake.

Cosmetic colors that are not subject to batch certification are known by more common names, for

example: Caramel or Henna. The important thing to note is that all of these colors, both those that are

subject to batch certification and those that are not, must be pre-approved, and have specifications set,

before being used in cosmetic products in the U.S.

Identification of the color additives on cosmetic product labels has been a discussion item between FDA

and industry for many years. Manufacturers would like to have a simpler system of identifying these color

additives, one that could be used world-wide so that all products would use the same terminology for the

same basic ingredients. FDA has been cautious in considering industry’s proposals in this area.

The FDA has granted permission for the cosmetic industry to use abbreviated names on the labels of

products containing the certifiable colors or lakes. For example, FD&C Blue No. 1 now may be listed as
Blue 1, and FD&C Red No. 40 Aluminum Lake may now be listed as Red 40 Lake

(http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.

htm). The original color names also may still be used.

FDA also allows companies marketing their products internationally to use dual labeling for colors, listing

names acceptable to the FDA as well as Colour Index (CI) numbers that are required for labeling colors in

the European Union and other countries in the world. Thus, for example, a cosmetic product in the U.S.

may bear ingredient labeling for colors such as Yellow 5/CI 19140 or FD&C Yellow No. 5/CI 19140.

The Council has asked FDA to allow listing of color additives on cosmetic products using only the CI

numbers, as is currently being done in the rest of the world. If this approach is accepted by FDA, the

following cross reference will enable consumers to find the FDA designation for the corresponding CI

Number. NOTE: Although there may be differing names allowed for color additives in the United States

and elsewhere, those used in products must still meet the regulatory requirements of the relevant

jurisdiction, regardless of the labeling name applied.

Color Additive Labeling Guide for Colorants Approved in the U.S.

EU Labeling Name FDA Color Additive Name Abbreviated Name

CI 10316 Ext. D&C Yellow No. 7 Ext. Yellow 7

CI 12085 D&C Red No. 36 Red 36

CI 14700 FD&C Red No. 4 Red 4

CI 15510 D&C Orange No. 4 Orange 4

CI 15800 D&C Red No. 31 Red 31

CI 15850 D&C Red No. 6 Red 6

CI 15850 D&C Red No. 7 Red 7

CI 15880 D&C Red No. 34 Red 34

CI 15985 FD&C Yellow No. 6 Yellow 6

CI 16035 FD&C Red No. 40 Red 40

CI 17200 D&C Red No. 33 Red 33

CI 19140 FD&C Yellow No. 5 Yellow 5

CI 20170 D&C Brown No. 1 Brown 1

CI 26100 D&C Red No. 17 Red 17

CI 42053 FD&C Green No. 3 Green 3

CI 42090 FD&C Blue No. 1 Blue 1

CI 42090 D&C Blue No. 4 Blue 4

CI 45350 D&C Yellow No. 7 Yellow 7

CI 45350 D&C Yellow No. 8 Yellow 8

CI 45370 D&C Orange No. 5 Orange 5

CI 45380 D&C Red No. 21 Red 21

CI 45380 D&C Red No. 22 Red 22

CI 45410 D&C Red No. 27 Red 27

CI 45410 D&C Red No. 28 Red 28

Banned (CI 45425) D&C Orange No. 10 Orange 10

Banned (CI 45425) D&C Orange No. 11 Orange 11

CI 47000 D&C Yellow No. 11 Yellow 11

CI 47005 D&C Yellow No. 10 Yellow 10

CI 59040 D&C Green No. 8 Green 8

CI 60725 D&C Violet No. 2 Violet 2

CI 60730 Ext. D&C Violet No. 2 Ext. Violet 2

CI 61565 D&C Green No. 6 Green 6

CI 61570 D&C Green No. 5 Green 5

CI 73360 D&C Red No. 30 Red 30

CI 77266 D&C Black No. 2 Black 2

CI 77267 D&C Black No. 3 Black 3

CI 75120 Annatto Annatto

CI 40800 Beta-Carotene Beta-Carotene

CI 75130

CI 75170 Guanine Guanine

CI 75470 Carmine Carmine

CI 75810 Chlorophyllin-Copper Chlorophyllin-Copper
Complex Complex

CI 77000 Aluminum Powder Aluminum Powder

CI 77007 Ultramarines Ultramarines

CI 77163 Bismuth Oxycholoride Bismuth Oxycholoride

CI 77288 Chromium Oxide Greens Chromium Oxide

Greens

CI 77289 Chromium Hydroxide Green Chromium Hydroxide

Green

CI 77400 Bronze Powder Bronze Powder

CI 77400 Copper Powder Copper Powder

CI 77489 Iron Oxides Iron Oxides

CI 77491

CI 77492

CI 77499

CI 77510 Ferric Ferrocyanide or Ferric Ferric Ferrocyanide or

Ammonium Ferrocyanide Ferric Ammonium
Ferrocyanide

CI 77742 Manganese Violet Manganese Violet

CI 77820 Silver Silver

CI 77891 Titanium Dioxide Titanium Dioxide

CI 77947 Zinc Oxide Zinc Oxide

Not Listed as a Color Bismuth Citrate (Hair Color Bismuth Citrate

Additive Only)

Caramel Caramel Caramel

Not Listed as a Color Dihydroxyacetone Dihydroxyacetone

Additive

Not Listed as a Color Disodium EDTA-Copper Disodium EDTA-

Additive Copper

Not Listed as a Color Guaiazulene Guaiazulene

Additive

Not Listed as a Color Henna (Hair Color Only) Henna

Additive

Banned Lead Acetate (Hair Color Lead Acetate

Only)

Not Listed as a Color Mica Mica

Additive

Not Listed as a Color Pyrophyllite Pyrophyllite

Additive

Not Listed as a Color Luminescent Zinc Sulfide Luminescent Zinc

Additive Sulfide