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When cosmetic product listing and label review should be bundled together

Choose the $249-per-product combined service when an applicable MoCRA product listing and a separate professional label review need coordinated information.

Author:
FDABridge Team
Published:
Read time:
2 minutes

Two related tasks with different legal purposes

A cosmetic product listing is an FDA submission by the label-named responsible person when section 607 applies. A label review is a professional assessment of the displayed identity, quantity, ingredients, business information, warnings, claims and applicable MoCRA text. The review itself is not an FDA filing or approval. Facility registration is a separate duty of the facility owner or operator, subject to exemptions.

Check the role and exemption first

Confirm who is named on the label as manufacturer, packer or distributor, whether the product is a cosmetic rather than a drug, and whether a small-business or other exemption applies. The responsible person need not automatically be a US company. Where listing is required, Form FDA 5067 asks for product and facility details; some closely related product variants may be included in one listing under FDA's rules. Do not equate a paid per-product service unit with one mandatory FDA filing per SKU.

Coordinate the information, then choose the service

A label change can affect the product name, ingredients or responsible-person information used in the listing. Reviewing both together can reduce rework, while the listing submission and label assessment remain distinct deliverables. FEI acquisition is another separate task when a facility needs it. FDABridge's $249-per-product combined offer covers listing assistance where applicable and one label review. The $1,249 Brand Launch offer has five product-listing service units and five label reviews alongside facility-registration assistance; eligible products may share an FDA listing. Confirm the actual product group and facility status before ordering.

FDA does not preapprove ordinary cosmetic labels, and a listing number does not signify FDA approval. See FDA's registration and listing guidance at https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products and its cosmetic labeling rules at https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-regulations . Compare the service choices at https://fdabridge.com/cosmetic-product-listing and https://fdabridge.com/cosmetics-label-review .