US regulatory guide

MoCRA product listing, explained.

Product listing is the MoCRA duty most often confused with facility registration, and most often wrongly delegated to the contract manufacturer. It belongs to the Responsible Person on your label, it runs through Cosmetics Direct, and it has to stay current as your range changes.

A cosmetic product listing being prepared in the FDA Cosmetics Direct portal

Reviewed by Cassandra Maddocks, chemist & biochemist · last reviewed 26 July 2026

What is the MoCRA product listing?

A submission to the FDA identifying each cosmetic product marketed in the US and its ingredients, made and maintained by the Responsible Person named on the label. It is separate from facility registration, free of charge, and filed through the FDA's Cosmetics Direct portal.

The duty comes from MoCRA's registration-and-listing provisions, summarised on the FDA's registration and listing page. The full US regime around it is in our complete MoCRA guide.

The FDA registration and listing page noting that FDA does not issue certificates for registrations or listings — The FDA's Registration and Listing page, with the note that FDA does not issue certificates for registrations or listings highlighted. Captured 26 July 2026. View the official text.

Who files it: my manufacturer or me?

You, if you are the Responsible Person on the label. MoCRA splits the two duties: the manufacturer registers the facility, but the Responsible Person submits and maintains the product listing and handles adverse-event reporting. "The factory handles the FDA stuff" is the most common listing mistake.

The split matters commercially too: a listing filed under your own control does not depend on any one manufacturing relationship. If your facility is foreign, registration additionally needs a US Agent, a separate role from the Responsible Person, though one firm can support both sides.

When is the listing due?

For a new product, within 120 days of it being marketed in the United States. Products already on sale at MoCRA's compliance deadline (1 July 2024, after the FDA's six-month enforcement delay) needed their initial listing by that date. Listings must then be kept current as the range changes.

Treat listing as an ongoing register of what you actually sell, not a one-time filing: discontinued products come off, new shades and formats go on, and the record has to match the market. That cadence is what our Compliance Care monitoring exists for.

How does Cosmetics Direct work?

Cosmetics Direct is the FDA's free electronic portal for registrations and listings. It authors submissions in Structured Product Labeling, an XML format used across FDA systems, and a small structural error can bounce a submission, which is why first-time filers find the format the hardest part.

The portal itself is at the FDA's Cosmetics Direct page; paper alternatives exist (Forms FDA 5066 and 5067) but the electronic route is faster and what the FDA prefers. We file in SPL routinely, which is most of what clients are paying to avoid.

Is anyone exempt from listing?

Qualifying small businesses (average gross annual US cosmetic sales under $1,000,000 over the previous three years, inflation-adjusted) are exempt from listing, unless they sell products in the higher-risk categories that void the exemption, such as eye-area products or injectables.

The threshold, the voiding categories and what an exempt firm still owes are covered in our small-business exemption guide. If you are over the line, or about to be, request a US compliance quote and we set up registration and listing together.

Sources

Primary sources cited in this guide. Regulatory status last verified 26 July 2026.