Quick Answer: Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the responsible person must list each cosmetic product marketed in the United States with FDA, including its ingredients, and provide updates annually. FDA identifies the responsible person as the manufacturer, packer or distributor whose name appears on the product label. A product listing is not FDA approval.
Last reviewed: September 13, 2026
What is a MoCRA product listing?
A MoCRA product listing is the information a responsible person submits to FDA for a cosmetic product marketed in the United States. FDA explains that the listing includes the product and its ingredients. The requirement sits alongside, rather than replaces, facility registration and the other obligations that may apply to cosmetics under federal law.
For an international beauty brand, the practical question is not simply whether a factory has registered. The brand should identify the labelled responsible person, maintain a controlled product record, and decide how ingredient, label and portfolio changes will be captured for the annual update.
Who is responsible for the listing?
FDA defines the responsible person as the manufacturer, packer or distributor whose name appears on the cosmetic product label in accordance with the applicable labelling provision. That name-on-label test makes label governance important: an overseas brand, importer and manufacturer should agree which legal entity will carry the role before product labels are finalised.
| Party | Typical contribution | What should be agreed in writing |
|---|---|---|
| Responsible person | Submits and maintains the FDA product listing. | Labelled entity, account ownership, update calendar and record access. |
| Brand owner | Controls the commercial product, claims and approved label version. | Who reports formula, label or market-status changes. |
| Manufacturer | Maintains production and technical information relevant to the product. | How current ingredient and batch documentation is supplied. |
| Importer or distributor | May support market entry and distribution records. | How it escalates complaints and market information to the responsible person. |
What information needs change control?
FDA’s listing framework calls for a product listing that includes ingredients. Rather than treating that as a one-time form, a B2B compliance process should connect it to the records used to approve the product and label.
| Controlled item | Why it matters | Practical owner |
|---|---|---|
| Product identity | Keeps the listed product aligned with the marketed SKU and label. | Brand owner with responsible person review. |
| Ingredient information | FDA states that product listings include ingredients. | Manufacturer supplies current information; responsible person maintains the record. |
| Labelled entity | It helps determine who is the responsible person. | Brand owner and legal/compliance team. |
| Market status | Supports a timely decision when an annual update is due. | Brand operations or regulatory lead. |
How annual updates fit into an operating process
FDA says the responsible person must provide updates to its cosmetic product listings annually. A simple operating rhythm can reduce preventable gaps:
- Maintain one approved record for each marketed product and its current label.
- Log changes to ingredients, product identity, labelled entity and marketing status when they occur.
- Review the record before the annual update window.
- Have the responsible person submit the required update and retain a dated confirmation in the compliance file.
Product listing vs facility registration
| Question | Product listing | Facility registration |
|---|---|---|
| Primary focus | A cosmetic product marketed in the United States. | A facility that manufactures or processes cosmetic products. |
| FDA page describes it as | A responsible-person obligation with ingredient information and annual updates. | A facility obligation renewed every two years. |
| Does it equal FDA product approval? | No. | No. |
Common mistakes to avoid
- Assuming a factory’s facility registration removes the brand’s need to determine its responsible person.
- Allowing a formula or label change to bypass the product-listing change log.
- Describing an FDA listing as an approval, certification or market-access guarantee.
- Leaving the name shown on the label and the entity operating the listing account unclear.
Official sources
| Source | Why it is relevant |
|---|---|
| FDA: Registration & Listing of Cosmetic Product Facilities and Products | FDA’s current overview of product listing, the responsible person and update timing. |
| FDA: Modernization of Cosmetics Regulation Act of 2022 | FDA’s MoCRA overview and related compliance responsibilities. |
Frequently asked questions
Is a MoCRA product listing the same as facility registration?
No. FDA treats product listing and facility registration as separate requirements. A product listing concerns a marketed cosmetic product; facility registration concerns a manufacturing or processing facility.
Does product listing mean FDA approved the cosmetic?
No. FDA states that registration and listing do not mean FDA approval of a cosmetic product.
Who must update a product listing?
FDA says the responsible person provides updates to cosmetic product listings annually.
Can a manufacturer provide information for the listing?
Yes. A manufacturer can provide technical records such as current ingredient information, but the parties should document who is the responsible person and who submits and maintains the listing.
MOOYAM provides cosmetic OEM/ODM manufacturing and technical documentation support for international beauty brands. Explore OEM / ODM, review our FDA cosmetic registration guide, or contact us to discuss your product file.
Regulatory requirements may change. Brands should verify current requirements with the relevant regulatory authority or qualified compliance professional before placing cosmetic products on the market.