Exporting Cosmetics to the US: FDA MoCRA Registration and Labels
Cosmetics need no FDA approval before sale in the US, except color additives. Under the Modernization of Cosmetics Regulation Act (MoCRA), the factory registers with FDA and the company named on the label (the responsible person) lists each product, reports serious adverse events and keeps safety evidence. Sunscreens follow OTC drug rules instead.
Checked against official sources: 2026-09
At a glance
Facility registration and product listing
FDA has enforced registration and listing since 1 July 2024. Filing is free in the Cosmetics Direct portal (paper forms also exist); failing to register or list is a prohibited act.
- Each facility that manufactures or processes cosmetics for the US registers, including foreign factories, which must name a US agent. A contract manufacturer needs one registration, filed by itself or a client brand.
- Sites that only label, pack, hold or distribute are not facilities.
- New facilities register within 60 days of starting and renew every two years; the first renewals came due in 2026.
- The responsible person lists each product, with its full ingredient list, within 120 days of first US marketing and updates listings yearly.
- Firms with average US cosmetic sales under USD 1 million a year (inflation-adjusted) are exempt, except for eye-area, injected, internal-use and long-lasting products.
The responsible person
This is the manufacturer, packer or distributor whose name appears on the label. It can be a foreign brand owner or a US importer, so agree who it is before printing labels.
It must report serious adverse events in the US to FDA within 15 business days and keep records showing adequate safety substantiation for each product. Existing safety data may be used.
US label requirements
Labels follow the FD&C Act, the Fair Packaging and Labeling Act and 21 CFR 701. Required statements must be in English, and imports must show the country of origin in English.
- Front panel: product identity and net quantity in US units (ounces or fluid ounces); metric may be added.
- Name and place of business, with "Manufactured for" or "Distributed by" if not the maker.
- Ingredients in descending order of predominance; those at 1% or less and colors may follow in any order.
- Since 29 December 2024: a US address, US phone number or electronic contact such as a website for adverse event reports.
- Warnings where required, for example on aerosols.
Sunscreens and other drug products
FDA classifies by intended use, shown by claims and ingredients. Sunscreens, SPF moisturizers and makeup, anti-dandruff shampoos and antiperspirants are drugs as well as cosmetics.
They must meet an OTC monograph (sunscreens: M020) or an approved application, use drug labeling with active ingredients first, and be made under drug GMP. The maker registers as a drug establishment and lists each product under 21 CFR 207, which gives it a National Drug Code. MoCRA cosmetic listing does not apply, nor cosmetic registration unless the site also makes ordinary cosmetics.
Sunscreens may use only monograph UV filters, in listed forms such as lotions, creams, sticks and sprays. FDA added bemotrizinol in June 2026 and removed PABA and trolamine salicylate in September 2026.
How FDA checks shipments at entry
The importer, usually via a licensed customs broker, files FDA data with the customs entry: product code, description, manufacturer and importer. FDA screens it and may release the goods, request labels, examine or sample them, or detain them.
Reviewers check labels, colors and drug-type claims. Colors must be approved for the use (eye area only if permitted), many need FDA-certified batches, and a CI or E number does not show certification.
After detention the importer normally has 10 business days to submit evidence or ask to relabel (Form FDA 766). Refused goods must be exported or destroyed within 90 days. FDA can also put firms or products on an import alert, allowing detention without physical examination.
Still pending in September 2026
FDA had not yet proposed the cosmetic GMP rule or the fragrance allergen labeling rule MoCRA requires; the law set mid-2024 for the allergen proposal. FDA withdrew its proposed talc asbestos testing rule in November 2025.
In September 2026 FDA confirmed it issues no registration certificates or letters; a registration number is not an approval.
Rules change. Confirm current requirements with FDA and a licensed customs broker or regulatory consultant.
Step by step
- Classify each product; SPF and anti-dandruff products take the OTC drug route.
- Check colors and, for sunscreens, the UV filters.
- Agree on the responsible person and build the safety substantiation file.
- Register the facility in Cosmetics Direct, then list each product.
- Finalize the English label, including the adverse event contact line.
- Set up complaint handling for adverse event reporting.
- Give the broker exact descriptions, manufacturer details and labels, with a matching invoice and packing list (Triplicate's free generator makes both).
- If FDA detains the goods, respond by the date in the notice.
Documents you usually need
- Commercial invoice and packing list
- Bill of lading or air waybill
- Final US label for each product
- Manufacturer details, FEI, and registration and listing numbers
- Full ingredient list and color certification details
- Safety substantiation records (held by the responsible person)
- For OTC drugs: drug establishment registration, drug listing and monograph compliance evidence
Common problems and how to avoid them
What to do: Check each color against FDA's color additive regulations for its use and keep certification lot details.
What to do: Check net quantity, ingredient order, business name and address, country of origin and the contact line before printing.
What to do: Remove the claims from labels and websites, or market the product as a drug.
What to do: Complete the monograph, drug registration, listing and labeling steps first.
What to do: FDA issues none; share registration and listing numbers instead.
Sources
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA) US Food and Drug Administration
- Registration & Listing of Cosmetic Product Facilities and Products US Food and Drug Administration
- Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2024) US Food and Drug Administration
- 21 U.S.C. 364e - Labeling (MoCRA) US Government Publishing Office
- Summary of Cosmetics Labeling Requirements US Food and Drug Administration
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) US Food and Drug Administration
- Questions and Answers: FDA's regulatory actions on over-the-counter sunscreen US Food and Drug Administration
- Color Additives and Cosmetics: Fact Sheet US Food and Drug Administration
- Importing Cosmetics US Food and Drug Administration
- Detention & Hearing Period for Imported Products US Food and Drug Administration
Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.
Common questions
Our products are made by a contract manufacturer. Who registers?
The factory needs one registration, filed by the manufacturer or a client brand. The company named on the label lists the products.
Is an SPF moisturizer a cosmetic in the US?
It is both a cosmetic and an OTC drug, so the sunscreen monograph, drug labeling, drug GMP and drug registration apply.
Must fragrance allergens be listed on labels now?
Not yet. MoCRA requires it, but FDA had not proposed the allergen rule as of September 2026. Keep allergen data from your fragrance supplier ready.
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