Cosmetic Product Listing
$75 per product
Product-listing support under FD&C Act section 607 when required. The label-named responsible person lists marketed cosmetics; this differs from facility registration.
What's included
- ✓ Product listing submission via FDA Cosmetics Direct
- ✓ Product name, category, and ingredient list filing
- ✓ Responsible Person information recorded
- ✓ Submission and available listing-status record; no FDA approval certificate
- ✓ Review of changes for annual listing updates
How It Works
Check who must list and gather information
Identify the manufacturer, packer or distributor named on the label as responsible person and check exemptions. Gather product name/category, ingredients and manufacturing facilities. A listing may cover identical formulations or variants differing only in color, fragrance, flavor or quantity; a separate FDA filing per SKU is not universal.
Prepare the applicable product listing
For a required listing, we prepare Form FDA 5067 information and submit through an available FDA route such as Cosmetics Direct. Use each applicable facility registration number, or the facility name and address where an exemption means no registration number is required.
Review status and maintain the record
We share the available submission/status record. Initial listing timing depends on first marketing and the statutory transition rules; a newly marketed product is generally listed within 120 days. The responsible person provides listing updates annually. FDA does not approve or certify cosmetics through listing.
Common questions
Is product listing required under MoCRA?+
When FD&C Act section 607 applies, the responsible person named on the product label lists each marketed cosmetic product; the facility owner/operator handles registration. Certain small businesses are exempt unless they handle specified higher-risk product types, and some drug/device products or facilities are outside these cosmetic requirements. Check scope before filing.
What information is needed per product?+
Form FDA 5067 calls for the responsible person's identity/contact, product name/category, ingredients and the relevant manufacturing or processing facilities. Use the facility registration number where required, or the exempt facility's name and address where that alternative applies. Broader safety and label records are separate obligations, not extra universal listing fields.
How many products can I list?+
Our professional service is $75 per product in the agreed scope. That billing unit differs from FDA's filing rules: eligible products with identical formulations, or variants differing only in color, fragrance, flavor or quantity, may be included in one listing. For larger portfolios, review the existing bundle scope and price before ordering.
What if I update a product formula?+
The responsible person provides updates to product listings annually under section 607(c)(5). Review a changed formulation, product, facility or responsible-person record to decide what listing action is needed; there is no universal 90-day formulation-change rule. Facility-registration changes have a separate generally 60-day amendment clock.
Related Articles
Cosmetic Product Listing Under MoCRA: Responsible Person, Grouping and Updates
Jul 10, 2026
Who lists cosmetics with FDA, what Form 5067 requires, when certain variants may share a listing, and how initial and annual updates work.
MoCRA Cosmetic Facility Registration: Who Registers and What Changed
Apr 7, 2026
A practical guide to facility owner/operator registration, the label-named responsible person, FEI, exemptions, renewal and product listing under FD&C Act section 607.
When cosmetic product listing and label review should be bundled together
Mar 11, 2026
Choose the $249-per-product combined service when an applicable MoCRA product listing and a separate professional label review need coordinated information.
Listing + label review in one?
The Cosmetic Product Listing + Label Review Bundle is $249 per product and combines listing assistance with a separate label review. The Cosmetics Brand Launch Bundle ($1,249) includes facility-registration assistance, five product-listing service units and five label reviews. Eligible products may share one FDA listing.