United States · Cosmetics

MoCRA Product Listing in the United States

A practical guide to MoCRA Product Listing for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it
Each cosmetic product marketed in the United States; Brand owners responsible for the product
Authority
U.S. Food and Drug Administration (FDA)
Legal basis
MoCRA, FD&C Act Section 613
Local representative
The responsible person must be identifiable on the label
Timeline
Before marketing; updates when formulations change
Cost
No published flat fee; confirm current portal requirements
If you do not comply
Listing removal, customs detention, and enforcement action

Who needs this

Documents you need

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

How to comply

  1. Compile product and ingredient data
  2. Submit the listing through the FDA portal
  3. Update the listing when the formulation changes

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: MoCRA Product Listing — United States
Product category: Cosmetics
Authority: U.S. Food and Drug Administration (FDA)
Legal basis: MoCRA, FD&C Act Section 613

Documents we already have:
  1. Brand and product names
  2. Complete ingredient list
  3. Responsible person name and contact details

Questions:
  1. Does our product fall under MoCRA Product Listing in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before marketing; updates when formulations change.

No published flat fee; confirm current portal requirements.

Common rejection reasons

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Is every SKU listed separately?

Products are listed individually. Grouping rules are limited, so plan for one listing per distinct product.

Who submits the listing?

The responsible person or an authorized representative submits and maintains the listing.

What changes require an update?

Formulation changes, product name changes, and discontinuation should be reflected in the listing.

How long does MoCRA Product Listing take?

Before marketing; updates when formulations change.

How much does MoCRA Product Listing cost?

No published flat fee; confirm current portal requirements.

What happens if I sell without it?

Listing removal, customs detention, and enforcement action.

Who regulates MoCRA Product Listing in the United States?

U.S. Food and Drug Administration (FDA).

Related requirements

See the full directory

Need this checked before launch?

Send the product, target market, and sales channel. You get a document checklist, the gaps, and the official route to fix them.

Request a pre-audit

Fixed fee $199 · report within 48 hours · free fit check first