US Cosmetic Color Additives
Which color additives can I use in cosmetics in the US?
In the US you can only use a color additive in a cosmetic if FDA has listed it for that use, and only within the conditions in its listing. The current eCFR (issued 2026-09-11) has 65 cosmetic listings. Twenty-nine are in 21 CFR Part 73 Subpart C and don't need certification. Thirty-six are in Part 74 Subpart C, and every batch of those must be certified by FDA. The full table with each color's conditions is in the panel document.
Exempt from certification (Part 73)
- Allowed in cosmetics generally, including near the eye: annatto, caramel, carmine, β-carotene, bismuth oxychloride, iron oxides, guanine, mica, titanium dioxide, bronze powder, copper powder, manganese violet and zinc oxide [1].
- External use only (eye area allowed): ferric ferrocyanide and ferric ammonium ferrocyanide, chromium hydroxide green, chromium oxide greens, aluminum powder and ultramarines.
- External use only, nothing said about the eye area: pyrophyllite, guaiazulene and dihydroxyacetone (for coloring the body).
- Limited to one product type:
- Bismuth citrate: scalp hair only, at no more than 2.0% (w/v) [2].
- Henna: hair only, never in the eye area.
- Disodium EDTA-copper: shampoos only.
- Copper chlorophyllin: dentifrices only, at no more than 0.1%.
- Silver: nail polish only, at no more than 1%.
- Luminescent zinc sulfide: facial makeup (no more than 10%, for occasional use only) and nail polish [3].
- Silver nitrate: professional-use eyebrow and eyelash tints only, at no more than 4%. It must not be used on anyone under 16 or sold to consumers [4].
- Carmine labeling: cosmetics with carmine that aren't covered by § 701.3 "shall" declare carmine prominently on the labeling [5].
Batch certification required (Part 74)
- Allowed including near the eye: FD&C Blue No. 1, FD&C Yellow No. 5 and D&C Green No. 5. FD&C Red No. 40 is allowed in cosmetics generally, but only the straight color and its Aluminum Lake may be used near the eye [6].
- Cosmetics generally (no eye-area use): FD&C Green No. 3, FD&C Yellow No. 6, D&C Red Nos. 6, 7, 21, 22, 27, 28 and 30, and D&C Yellow No. 10.
- External use only: D&C Blue No. 4, D&C Brown No. 1, D&C Green No. 6, D&C Orange Nos. 4, 10 and 11, FD&C Red No. 4, D&C Red Nos. 17, 31 and 34, D&C Violet No. 2, Ext. D&C Violet No. 2, D&C Yellow Nos. 7, 8 and 11, and Ext. D&C Yellow No. 7.
- With concentration limits:
- D&C Green No. 8: external use, at no more than 0.01% [7].
- D&C Orange No. 5: lip products at no more than 5.0%; also mouthwashes, dentifrices and external use [8].
- D&C Red No. 33: lip products at no more than 3%; also mouthwashes, dentifrices and external use [9].
- D&C Red No. 36: lip products at no more than 3%; also external use.
- Named products only:
Rules that cut across all listings
- Eye area and injection: a color permitted for general or external use may not be used near the eye, in injections or in surgical sutures unless its listing says so. FDA's status list states that currently no color additive is listed for injected products such as tattoos or permanent makeup [12].
- Lakes: FD&C lakes are provisionally listed for foods, drugs and cosmetics (§ 82.51). D&C and Ext. D&C lakes are provisionally listed for external cosmetics only (§§ 82.1051 and 82.2051). Both require certification [13].
- Certified colors in general: colors listed in Parts 74 and 82 must be batch-certified by FDA before use in any product sold in the US, including imports [12].
- Coal tar hair dyes: a coal tar hair dye containing an ingredient listed in § 740.18(b) must carry a cancer warning on its principal display panel [14].
Approach: I read the current eCFR text of 21 CFR Parts 73 and 74 (cosmetics subparts) and the cosmetics regulations in Parts 700-740, and checked FDA's Regulatory Status of Color Additives list (edition of 08/14/2026). The text of Part 70 and Part 82 isn't in the datasets I can search, so the lake and eye-area rules above come from FDA's status list rather than the regulations themselves.
Which colors are allowed in eye makeup and lip products?
In the US, 25 color additives can be used in eye makeup and 31 in lip products. This follows from two definitions in 21 CFR 70.3:
- Eye area (§ 70.3(s)): the area inside the supra-orbital and infra-orbital ridges, including the eyebrow, the skin below it, the eyelids, the eyelashes and the eye itself.
- Externally applied cosmetics (§ 70.3(v)): cosmetics applied "only to external parts of the body and not to the lips or any body surface covered by mucous membrane" (eCFR § 70.3).
So an "externally applied" color can never go in a lip product. A color listed for general or external use can't go near the eye unless its listing says so [15].
Eye makeup (25 colors)
Exempt from certification (Part 73), 19 colors listed "including eye area":
- annatto
- caramel
- carmine [5]
- β-carotene
- bismuth oxychloride
- iron oxides [1]
- ferric ammonium ferrocyanide
- ferric ferrocyanide
- chromium hydroxide green
- chromium oxide greens
- guanine
- mica
- titanium dioxide
- aluminum powder
- bronze powder
- copper powder
- ultramarines
- manganese violet
- zinc oxide
Batch-certified (Part 74), 6 colors:
- FD&C Blue No. 1, including its Aluminum Lake [16]
- FD&C Yellow No. 5, including its Aluminum Lake (subject to § 70.5(b) and (c)) [17]
- D&C Green No. 5
- FD&C Red No. 40: only the straight color and its Aluminum Lake [6]
- D&C Black No. 2: eyeliner, brush-on-brow, eye shadow and mascara (among the products it is limited to) [10]
- D&C Black No. 3: eyeliner, eye shadow and mascara (among the products it is limited to); it must also comply with § 700.27 [11]
Eye-area colors with restrictions or exclusions:
- Silver nitrate: limited to professional-use eyebrow and eyelash tints at no more than 4%. It is not for anyone under 16 and is not sold to consumers [4]. It isn't included in the 25 above.
- Henna: expressly excluded from eyelashes, eyebrows and the eye area [18].
- Bismuth citrate: expressly excluded from eyelashes and eyebrows [2].
- Luminescent zinc sulfide: its facial-makeup listing doesn't mention the eye area, so it doesn't qualify.
Lip products (31 colors)
Exempt from certification (Part 73), 13 colors listed for cosmetics generally: annatto, caramel, carmine, β-carotene, bismuth oxychloride, iron oxides, guanine, mica, titanium dioxide, bronze powder, copper powder, manganese violet and zinc oxide (same Part 73 citations as above). Ferric ferrocyanides, chromium greens, aluminum powder, ultramarines, pyrophyllite, guaiazulene and dihydroxyacetone are listed only for externally applied cosmetics, so they can't go on the lips.
Batch-certified (Part 74), 14 colors listed for cosmetics generally:
- FD&C Blue No. 1
- FD&C Green No. 3
- D&C Green No. 5
- D&C Red No. 6
- D&C Red No. 7
- 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
- FD&C Red No. 40
- FD&C Yellow No. 5
- FD&C Yellow No. 6
- D&C Yellow No. 10
Batch-certified (Part 74), 4 colors listed by name for lip products:
- D&C Orange No. 5: lip products at no more than 5.0% by weight [8]
- D&C Red No. 33: lip products at no more than 3% total color by weight [9]
- D&C Red No. 36: lip products at no more than 3% total color by weight [19]
- D&C Black No. 2: lipstick [10]
Lakes
- FD&C lakes are provisionally listed for cosmetics [12], so they can go in lip products. For the eye area, the only lakes listed are the Aluminum Lakes of FD&C Blue No. 1, FD&C Yellow No. 5 and FD&C Red No. 40.
- D&C and Ext. D&C lakes are provisionally listed only for external cosmetics [13]. Under § 70.3(v), that rules out lip products, and they have no eye-area listing either.
Every color in the Part 74 lists has to be batch-certified by FDA before use.
Approach: I checked the current eCFR text of 21 CFR Parts 73 and 74 (cosmetics subparts) against FDA's Regulatory Status of Color Additives list. Part 70 isn't in the datasets, so I took the eye-area and "externally applied" definitions from § 70.3 on the official eCFR.
How are lakes and coal tar hair dyes treated?
Lakes are certified colors in their own right: every lake must be batch-certified by FDA and may be used only where its listing allows. Coal-tar hair dyes are the one statutory exception to color additive approval. They don't need FDA approval as long as the label carries the caution statement set out in the FD&C Act and the product comes with skin-test directions. Separately, any coal-tar hair dye containing 2,4-diaminoanisole or its sulfate must carry a cancer warning under 21 CFR 740.18.
Lakes
What a lake is. FDA defines a lake as "a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination," not a simple mixture (21 CFR 70.3(l)). Because lakes don't dissolve in water, they are used where a color must not "bleed," as in lipstick (FDA Color Additives and Cosmetics fact sheet).
Where they are listed. Most lakes are only provisionally listed, under 21 CFR 81.1. A few are permanently listed in Part 74 [12].
| Lake group | Status | Cosmetic use | Regulation |
|---|---|---|---|
| FD&C lakes | Provisional, certification required | Foods, drugs and cosmetics | § 82.51 [12] |
| D&C and Ext. D&C lakes | Provisional, certification required | External drugs and external cosmetics only | §§ 82.1051, 82.2051 [13] |
| All FD&C Red No. 40 lakes | Permanent | Cosmetics (§ 74.2340) | Part 74 [12] |
| FD&C Blue No. 1 and FD&C Yellow No. 5 Aluminum Lakes | Permanent | Drugs and cosmetics (§§ 74.2101, 74.2705 for cosmetics) | Part 74 [12] |
What Part 82 requires (eCFR Part 82):
- FD&C lakes (§ 82.51): made by extending a certified water-soluble straight color, combined with aluminum or calcium, on an alumina substratum. They must be made from previously certified colors. Limits are no more than 2.0% soluble chlorides and sulfates and no more than 0.5% HCl-insoluble inorganic matter. The name follows the pattern "FD&C Blue No. 1—Aluminum Lake."
- D&C (§ 82.1051) and Ext. D&C (§ 82.2051) lakes: a much wider range of substrata is allowed, including alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate and calcium carbonate, alone or combined. Limits are no more than 0.5% ether extracts, 3.0% soluble chlorides and sulfates, and 0.2% intermediates.
Eye area. Only three lakes are listed for cosmetics used around the eye:
- FD&C Blue No. 1 Aluminum Lake "may be safely used" in eye-area cosmetics [16].
- FD&C Yellow No. 5 Aluminum Lake may be used the same way, subject to § 70.5(b) and (c) [17].
- FD&C Red No. 40 Aluminum Lake [6].
The Blue No. 1 and Yellow No. 5 Aluminum Lakes "shall be prepared" in line with § 82.51 [20][21].
Certification and labels. Every color listed in Parts 74 and 82 must be batch-certified by FDA before use, and that applies to imports too. The certified color's label must show its name, its use limits, any quantity limits and the certification lot number [13].
Coal-tar hair dyes
The exemption. Coal-tar hair dyes, "unlike color additives in general, do not need FDA approval" (FD&C Act 601(e)). Under FD&C Act 601(a), FDA cannot act against one for containing a poisonous or deleterious ingredient, as long as two conditions are met. First, the label must carry this caution statement:
"Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness."
Second, the product must come with adequate skin-test directions (FDA Hair Dyes, updated 09/25/2025). FDA also says that, apart from coal-tar hair dyes, a cosmetic that fails the color additive requirements is adulterated (fact sheet).
Scope. The exemption covers permanent, semi-permanent and temporary hair dyes, but not eyebrow or eyelash dyes. Any color for brows or lashes needs FDA approval for that use (FDA Hair Dyes).
The two sources don't agree on brow and lash colors. FDA's Hair Dyes page says "No color additives are approved for dyeing the eyebrows or eyelashes." The current Part 73 text, as I reported last time, lists silver nitrate for professional-use eyebrow and eyelash tints at no more than 4% [4]. The regulation governs.
Cancer warning (§ 740.18). The principal display panel and any accompanying labeling of a coal-tar hair dye containing a § 740.18(b) ingredient "shall bear" this warning: "Warning—Contains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals" [14]. The § 740.18(b) ingredients are 4-methoxy-m-phenylenediamine (2,4-diaminoanisole) and its sulfate [22].
Hair colors that are not coal-tar. These get no exemption and need a color additive listing:
- Henna and bismuth citrate are listed, with the limits I gave last time.
- Lead acetate is delisted. It was formerly listed for scalp-hair coloring at no more than 0.6% w/v Pb, and the listing was terminated through rules from 2018 to 2021 [23]. FDA says the final rule took effect on January 6, 2022 (FDA Hair Dyes).
Approach: I checked FDA's Regulatory Status of Color Additives list (08/14/2026 edition) and the current eCFR text of 21 CFR Part 74 and Parts 700-740. The FD&C Act and Part 82 aren't in the datasets, so the statutory exemption comes from FDA's Hair Dyes page and the lake specifications from the official eCFR Part 82.