FDA Cosmetics Registration and Product Listing Under MoCRA: A Seller Guide
If you make or sell skincare, makeup, hair care or fragrance in the US, FDA rules changed a lot under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Facilities now have to register with the FDA, products have to be listed, and serious adverse events must be reported. This guide explains who has to do what, with a focus on Chinese factories and brands selling through Amazon, Walmart and TikTok Shop.
This is a general overview, not legal advice. Check FDA's pages or a regulatory consultant for your specific products.
Two separate obligations: facilities and products
- Facility registration. "Manufacturers and processors must register their facilities with the FDA and renew their registration every two years," according to FDA's registration and listing page (current as of Sept 9, 2026). This applies to the factory, wherever it is, if it makes or processes cosmetics for the US market. Foreign facilities also name a US agent in their registration.
- Product listing. "A responsible person must list each marketed cosmetic product with the FDA, including product ingredients," and update the listing every year. The responsible person is the manufacturer, packer or distributor whose name appears on the label, which is often the brand, not the factory.
Both are filed electronically, mainly through FDA's free Cosmetics Direct portal, which FDA describes as a Structured Product Labeling (SPL) authoring tool.
How many companies have done it
FDA publishes running totals. As of June 30, 2026, it reported the following:
| FDA cosmetics data (as of June 30, 2026) | Count |
|---|---|
| Unique, active facility registrations | 16,398 |
| Unique, active product listings | 1,298,361 |
Source: FDA, Registration & Listing of Cosmetic Product Facilities and Products. Your competitors are already in the system; buyers and marketplaces increasingly expect you to be too.
Other MoCRA duties for the responsible person
- Serious adverse event reports must go to FDA within 15 business days, with a copy of the label, according to FDA's MoCRA overview (current as of Aug 10, 2026). New medical information received within a year must also be sent within 15 business days.
- Safety substantiation records must be kept. FDA notes that animal testing is not a requirement for marketing a cosmetic product.
- Records access and recalls. FDA can access certain safety records and can order a mandatory recall if a company refuses a voluntary one and a product may cause serious harm.
- Fragrance allergen labeling will be set by a future FDA regulation, so watch for updates.
The small business exemption
MoCRA exempts certain small businesses from facility registration and product listing. FDA's small business form defines this as a business whose average annual US cosmetic sales over the previous three years are under $1,000,000, adjusted for inflation, per FDA's small business exemption form.
The exemption does not apply to products that are injected, intended for internal use, or that regularly come into contact with the mucous membrane of the eye, according to FDA. A brand with low sales that sells mascara or eyeliner, for example, still needs to register and list. Also note that products regulated as drugs (sunscreens, for example) follow FDA's drug rules instead.
Who does what: factory vs brand
| Task | Usually done by |
|---|---|
| Register the manufacturing facility (renew every 2 years) | The factory (with its US agent if outside the US) |
| List each product and its ingredients (update yearly) | The responsible person named on the label (often the brand) |
| Report serious adverse events within 15 business days | The responsible person |
| Keep safety substantiation records | The responsible person |
Product listings reference the facility's registration number, so brands need that number from their factory before listing.
Step-by-step checklist
- Confirm each product is a cosmetic (not a drug) under FDA definitions.
- Work out whether you qualify for the small business exemption, and whether any product falls outside it.
- Ask your factory for its FDA facility registration number, or help it register.
- Decide who is the responsible person on the label and make sure the label contact details are correct.
- Create a Cosmetics Direct account and list each product with its full ingredient list.
- Set calendar reminders: annual listing updates and two-year facility renewals.
- Set up a process to log complaints and report serious adverse events within 15 business days.
- Keep safety substantiation files ready in case FDA or a marketplace asks.
Keep your FDA registration and listing numbers handy. Marketplaces and retail buyers often ask for compliance documents when you launch beauty products or when a listing is flagged.
For the rest of your launch paperwork, see our US market entry checklist.
How Atronia Innovations can help
We help Chinese factories and brands launch beauty and personal care products on Amazon, Walmart and TikTok Shop, from compliant listings to ads and fulfillment, and we work alongside your regulatory advisers. Explore our Brand Accelerator or talk to our team.
