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U.S. Cosmetic Labeling Requirements: FDA and MoCRA

Label problems are one of the most common reasons cosmetics are held at the U.S. border or removed from online stores. These are the main FDA label rules.

Updated November 2026By Regovant LLC6 min read

The front panel

  • Statement of identity: what the product is, such as "moisturizing face cream".
  • Net quantity of contents: in the bottom third of the front panel, in both U.S. units (oz or fl oz) and metric units (g or mL).

The information panel

  • Ingredient list: in descending order of amount, using the names FDA requires. Ingredients under 1% can be listed in any order after the others, and colors can be listed at the end. Fragrance can be declared as "fragrance".
  • Company name and place of business: of the manufacturer, packer or distributor. If it is not the manufacturer, it must say so, for example "Distributed by".
  • Warnings: required for some product types, such as aerosols, and for products whose safety has not been substantiated.
  • Directions for safe use, where needed.

What MoCRA added

  • Adverse event contact: the label must show a U.S. address, U.S. phone number, or electronic contact such as a website, where the Responsible Person can receive reports of adverse events.
  • Professional use: products only for licensed professionals must say so clearly on the label.
  • Fragrance allergens: MoCRA requires FDA to set rules on fragrance allergens that must be named on labels. FDA has not issued this rule yet, so check before each label update.

Language and claims

Required information must be in English. If the label also uses another language, all required information must appear in that language too.

Claims matter as much as the panels: words like "treats acne", "regrows hair" or "SPF" make a product a drug under U.S. law. See cosmetic or drug?

"Made in" labels are a U.S. Customs rule, not an FDA one. Imported products usually need country of origin marking.

Questions

Can I use EU INCI names on a U.S. label?

Mostly, but not always. FDA has its own required names, and some differ from EU INCI names, for example for colors and botanicals. Check each ingredient.

Does FDA review labels before sale?

No. FDA does not approve cosmetic labels in advance. The company is responsible for getting them right.

Can Regovant review our label?

Yes. We review your existing artwork and send suggested corrections on it, with a short written report, for $369 per product.

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.

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