US cosmetic labeling combines long-standing rules in 21 CFR Parts 701 and 740 with applicable MoCRA duties. FDA does not preapprove ordinary cosmetic labels. A professional label review can identify issues, but it is neither an FDA submission nor a guarantee of compliance or market entry. Check the product's actual cosmetic or drug status and the label used in the US market.
Principal display panel and net quantity
The principal display panel is the part most likely shown to consumers at retail. It generally carries the product identity and an accurate net-quantity declaration. The FDA cosmetic labeling guide describes the required US customary quantity expression and says metric units may also be stated; do not treat dual metric and customary declaration as a new universal MoCRA requirement. Size, placement and package exceptions depend on the product.
Information panel, ingredients and warnings
The information panel generally carries the name and place of business of the manufacturer, packer or distributor, an ingredient declaration using names permitted under 21 CFR 701.3, and applicable directions or warnings. Ingredient order and exceptions must be checked against the actual formula and package. INCI terminology alone is not a universal substitute for FDA's accepted ingredient naming. Certain warnings are product specific; a professional-use product has an applicable MoCRA professional-use label duty.
MoCRA contact and pending fragrance rule
MoCRA requires a domestic address, domestic phone number or electronic contact on the label through which the responsible person can receive adverse-event reports. The label-named responsible person is the manufacturer, packer or distributor identified under the statute; it is not automatically a US entity. FDA has been directed to issue fragrance-allergen labeling regulations, but a pending rule is not a present universal ingredient-list requirement. Check current FDA action before changing the artwork solely for a proposed provision.
Keep listing and facility registration separate
Where section 607 applies, the label-named responsible person submits the cosmetic product listing. The facility owner or operator handles facility registration where required; FEI acquisition, if needed, is another separate step. Small-business and other exemptions can change whether either filing is required. Neither filing is the label review, and none means FDA approved the product. Claims that make a product a drug may trigger a different pathway; classify the actual claim rather than assuming every cosmetic claim needs drug premarket approval.
Choose a review or coordinated listing service
FDABridge's cosmetic label review is $249 per label. The separate $249-per-product Listing + Label Review offer combines listing assistance where applicable with one professional label review. Confirm the responsible person, facility status, product grouping and exact service unit first. FDA's cosmetic labeling guide is at https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide and its MoCRA information is at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra . Compare https://fdabridge.com/cosmetics-label-review and https://fdabridge.com/cosmetic-product-listing .
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