Color additives in cosmetics and FDA permitted-use rules
US cosmetic color additives need FDA permission for their intended use. Check eye and lip restrictions, batch certification, lakes and hair dye exceptions.
In the US, color additives in cosmetics must be FDA-listed for their intended use, except for certain coal-tar hair dyes. Some require batch certification too, while exempt colors still must meet their listing's specifications and restrictions. FDA's cosmetics fact sheet explains these requirements.
A pigment permitted in eye shadow may lack permission for lipstick. Before choosing a cosmetic colorant, check the exact color, its form and where the finished product will be applied. FDA treats these permissions separately in its cosmetics color table.
How to check FDA's cosmetic color permissions
Start with FDA's list of color additives permitted in cosmetics. It separates eye-area use, cosmetics generally including lipsticks, externally applied cosmetics and certification status. Use it to find a candidate color, then read the individual listing's conditions.
The table is a quick reference. Its displayed content-current date is April 5, 2022, so check the current individual listing too. A tick in a summary table does not replace the applicable specifications or restrictions.
For lip products, don't rely on an external-use permission. Under section 70.3, externally applied cosmetics exclude the lips and surfaces covered by mucous membrane. Check permission for cosmetics generally, including lipstick, and any limits in the specific listing.
Eye-area permission needs its own check. Section 70.5 requires the listing or certification to provide specifically for that use. General cosmetic permission alone is insufficient. Batch certification alone does not establish it either.
This distinction affects formulation choices. Ultramarines have eye-area and external-cosmetic permission, but FDA's table does not list them for cosmetics generally, including lipstick. D&C Red No. 7 straight color has general cosmetic permission, but no eye-area permission in that table. FDA lists both examples.
Examples of permitted cosmetic colors
The following examples show why a single list of "FDA approved cosmetic colorants" can mislead. Each yes refers to a permitted category, subject to the listing's specifications, restrictions and certification requirements. It does not establish suitability for a finished formula.
| Color and form | Eye-area cosmetics | Cosmetics generally, including lipstick | External cosmetics | Batch certification |
|---|---|---|---|---|
| Iron oxides | Yes | Yes | Yes | Exempt |
| Ultramarines | Yes | No | Yes | Exempt |
| Chromium oxide greens | Yes | No | Yes | Exempt |
| D&C Red No. 7 straight color | No | Yes | Yes | Required |
| FD&C Blue No. 1 straight color | Yes | Yes | Yes | Required |
Source: FDA's cosmetics color table. These are illustrative entries, not the full inventory.
The individual listings add detail. Ultramarines are permitted in externally applied cosmetics, expressly including the eye area, at amounts consistent with good manufacturing practice. D&C Red No. 7 is permitted in cosmetics generally at current-good-manufacturing-practice amounts and requires batch certification. That general permission does not supply express eye-area authorization.
Don't confuse D&C Red No. 7 with FD&C Red No. 3. FDA denied permanent authorization for Red No. 3 in cosmetics and topical drugs in 1990. Recent food-related action does not represent a new cosmetics ban. See FDA's Red No. 3 overview.
A color's permitted status is not FDA approval of the finished cosmetic. Keep that distinction in formulation records and claims about the product. The useful question is whether this exact color meets the conditions for this intended use, as explained in FDA's fact sheet.
Certified colors and natural cosmetic colorants
Permission for a use and batch certification answer different questions. First establish whether the color can be used in the intended cosmetic. Then check whether its batches require certification. FDA separates colors subject to certification from those exempt from certification.
Exempt does not mean unrestricted. Identity, purity specifications, permitted uses, restrictions and labeling requirements still apply. Colors obtained primarily from mineral, plant or animal sources may be exempt from certification. Natural origin is not a general approval exemption.
Nor does exemption mean every pigment is naturally sourced. The ultramarines listing describes pigments manufactured by calcination and exempts them from certification. Check the listing rather than using "natural" or "synthetic" as a substitute for regulatory status.
The same caution applies to natural hair color additives. FDA says plant- and mineral-derived hair coloring materials need approval and listing like other color additives. They cannot use the coal-tar hair dye exception.
Check lakes separately from straight colors
A supplier's parent-dye name is not enough to establish a lake's permission. Identify the exact form, then check the intended use. FDA's cosmetics table excludes lakes from its eye-area column unless specifically noted. Its notes refer to designated aluminum lakes on alumina, not every lake of a permitted straight color. See the table and its notes.
FD&C Blue No. 1 illustrates an express permission. Its listing permits the straight color in cosmetics generally, including the eye area. It separately permits its Aluminum Lake for eye-area cosmetics when prepared under section 82.51. Batch certification is required.
The D&C Red No. 7 lipstick example above rests on its straight-color listing. For a lake, check the applicable listing for that form and intended use. The parent dye's permission alone does not settle the question.
Broad lake rules also have limits. Section 82.2051 concerns Ext. D&C lakes specifically, with conditions for eligible colors, salts and substrata. It is not a general permission for all D&C lakes. Nor does it establish lip or eye-area permission for every lake made from a listed color.
The limited coal-tar hair dye exception
Coal-tar hair dyes have a special exception from color-additive approval. That exception does not remove all adulteration or misbranding controls, including controls on harmful ingredients other than the dye. FDA's hair dye guidance explains the boundary.
The law's special treatment of coal-tar hair dyes depends on the required label caution and adequate preliminary skin-test directions. The caution warns of possible skin irritation and calls for a preliminary test according to accompanying directions. It also warns against dyeing eyelashes or eyebrows because doing so may cause blindness. Follow the required wording and directions, rather than inventing a universal test protocol.
The coal-tar exception does not cover eyebrow or eyelash dyes. But that does not mean every brow or lash color is prohibited. Section 73.2550 specifically permits silver nitrate for professional-use eyebrow and eyelash coloring under narrow conditions.
The silver nitrate listing sets concentration and application limits, prescribed warnings and directions, and prohibits direct consumer sale or distribution. The product must not be intended for people under 16. Read that specific regulation before considering the use. The coal-tar hair dye exception cannot replace this authorization.
A pre-formulation check
Use this sequence before selecting a pigment for cosmetics:
- Record the supplier's exact color name and form for the proposed formula, including whether it is a straight color or lake.
- Check the intended product category, with separate attention to lips and the eye area.
- Read the individual listing's specifications, restrictions and permitted amounts.
- Confirm whether batch certification is required.
These checks follow the distinctions in FDA's cosmetics fact sheet and permitted-color table.
RegAffairs AI answers which color additives can be used in US cosmetics, with source citations. The applicable FDA listing sets the permitted use and conditions.