The short answer
For makeup, colors are the biggest US risk. FDA says color additive violations are a common reason imported cosmetics are detained. Every color must be approved, used only for its listed purposes, and — for many colors — come from an FDA-certified batch.
| Requirement | What it means | Who |
|---|---|---|
| Facility registration (MoCRA) | Facilities that manufacture or process cosmetics for the US register with FDA and renew every two years | The manufacturing facility |
| Product listing | Each product is listed with its ingredients, and updated every year | The Responsible Person |
| Label | English label: identity, net quantity, ingredients in descending order, name and place of business, warnings, and a contact for adverse event reports | The brand |
| Approved colors | Each color approved for that use (eye area, lips, general); certified batches where required | The brand / manufacturer |
| Safety substantiation | Records showing the product is safe as used | The Responsible Person |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days | The Responsible Person |
The three color rules
- 1ApprovedAll color additives in cosmetics must be approved by FDA and meet their identity and specifications.
- 2Approved for this useA color can only be used as its regulation lists — near the eyes only if eye-area use is allowed; on the lips only if lip use is allowed. “Externally applied” does not include the lips or mucous membranes.
- 3Certified, if certifiableColors named like “FD&C …” or “D&C …” may only be used from batches FDA has certified. Colors exempt from certification (for example many mineral and plant-derived colors) still must meet every other rule.
Common problems
- CI numbers only: a color identified only by a CI or E number has not been FDA-certified. Ask suppliers for the FDA name and certification lot number.
- Eye products with lip or general colors: eyeliner, mascara and eyeshadow need colors approved for the eye area.
- Special effects: FDA says liquid crystal colors are not approved; only certain fluorescent colors are approved, and only luminescent zinc sulfide for glow-in-the-dark effects.
- Tattoo and permanent makeup: no color additives are listed as approved for injection.
Label points
- Ingredient list in descending order; colors listed with their US names.
- Products sold in several shades can use a “may contain” list for colors, under FDA's labeling rules.
- Name and place of business, net quantity, warnings, and a contact for adverse event reports.
Example
A makeup brand in South Korea preparing an eyeshadow palette for the US checks each of its 12 shades against FDA's list of colors permitted in cosmetics, replaces one red that is not approved for eye-area use, and buys its D&C colors from FDA-certified batches. Its factory is registered under MoCRA and each palette is listed.
What FDA does — and does not do — for cosmetics
FDA does not approve cosmetic products or their labels before they are sold (color additives are the exception). Registration and listing are not an approval, so never write “FDA approved” or “FDA certified” on a cosmetic label or website. Under MoCRA, the brand carries the responsibility: it must be able to show the product is safe as used, and FDA can inspect records, ask for safety information and, in serious cases, suspend a facility's registration or order a recall.
At the US border, FDA reviews imported cosmetics and can detain a shipment that appears adulterated or misbranded — for example a wrong or missing English label, an unapproved color, a prohibited ingredient or drug claims. Detained goods must be brought into compliance, exported or destroyed, so it pays to fix problems before the first shipment.
Small businesses: what MoCRA exempts
MoCRA exempts certain small businesses from facility registration, product listing and GMP. The exemption does not cover products that regularly touch the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Labeling, safety substantiation and adverse event reporting are not on the exempt list — and many US retailers and marketplaces ask for registration and listing anyway.
Step by step: selling your makeup in the US
- 1Decide: cosmetic, drug or bothYour claims and ingredients decide it. A drug needs drug registration, listing and Drug Facts labeling.
- 2Register the manufacturing facilityUnder MoCRA, and renew every two years. Foreign facilities name a U.S. Agent.
- 3List every productThe Responsible Person lists each product with its ingredients and updates the listing every year.
- 4Make the label US-readyEnglish text, ingredient list, warnings, contact for adverse events — and the product-specific points above.
- 5Keep safety records and an adverse event processSafety substantiation on file; serious adverse events reported within 15 business days.
Checklist
- Every color approved and approved for that area (eyes, lips, general)
- Certifiable colors from FDA-certified batches; FDA names on the label
- No unapproved special-effect colors
- MoCRA facility registration and product listing done
- Safety records and adverse event process in place
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Do all colors in cosmetics need FDA approval?
Yes. FDA says all color additives used in cosmetics must be approved, and each may only be used as its regulation allows. Coal-tar hair dyes with the required caution statement are the exception.
What is batch certification?
Certifiable colors — usually named like “FD&C Yellow No. 5” or “D&C Red No. 7” — may only be used if FDA has certified the specific batch. Colors exempt from certification still have to meet all other requirements.
Can I use a color in eyeshadow if it is allowed in lipstick?
Not automatically. A color can be used in the eye area only if its regulation allows eye-area use, and “externally applied” does not include the lips or mucous membranes. Check the listed uses for every color in every product.
Are CI numbers enough on a US label?
A color with only a CI or E number has not been FDA-certified. US labels use the FDA names, and certifiable colors must come from FDA-certified batches.
Who is the Responsible Person under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. The Responsible Person lists the products, keeps safety records and reports serious adverse events to FDA within 15 business days.
Are small cosmetic businesses exempt from MoCRA?
Certain small businesses are exempt from facility registration, product listing and GMP — but not for products that touch the eye’s mucous membrane, injected products, products for internal use or products that change appearance for more than 24 hours. Labeling, safety records and adverse event reporting still apply.
Sources
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (content current as of Oct 29, 2026)
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- FDA — Color Additives and Cosmetics: Fact Sheet
- FDA — Color Additives Permitted for Use in Cosmetics
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.