Who lists the products
The Responsible Person lists each product. This is the manufacturer, packer or distributor whose name appears on the label, usually the brand owner. If a contract manufacturer makes your products, you still list them; the manufacturer registers its own facility.
What a listing includes
- The facility registration number of each facility that makes or processes the product
- The name and contact details of the Responsible Person, and the brand name on the label
- The product category, such as lipstick, shampoo or face cream
- The full list of ingredients, including fragrances, flavors and colors
- The product name as it appears on the label
One listing can cover several products that have the same formula and differ only in color, fragrance, flavor or amount.
Deadlines
| New product | List within 120 days of first marketing it in the U.S. |
|---|---|
| Existing listings | Update every year, even if nothing changed |
| Product taken off the market | Update the listing to show it is discontinued |
How listings are submitted
Listings go to FDA electronically, usually through FDA's Cosmetics Direct portal. FDA gives each listing a product listing number. FDA charges no fee.
Common listing mistakes
- Listing before the facility is registered: the listing needs the facility's registration number.
- Incomplete ingredient lists: fragrance, flavor and color ingredients must be included.
- Wrong facility linked: after a change of manufacturer, listings must be updated.
- Forgetting the annual update: listings that are not updated become out of date.
Questions
Is product listing the same as facility registration?
No. Registration covers the facility that makes the product. Listing covers each product and is done by the brand owner named on the label.
Do I need a separate listing for each shade?
Not always. Products with the same formula that differ only in color, fragrance, flavor or quantity can share one listing.
Can Regovant list our products?
Yes. We prepare and submit each listing for $269 per product, link it to your facility registration and remind you before the annual update.
How Regovant can help
Regovant LLC registers cosmetic facilities under MoCRA, lists your products and acts as your U.S. Agent. Facility registration with U.S. Agent service is $369 per year, product listing is $269 per product and a cosmetic label review is $369 per product. See the cosmetics service, all guides or prices.