US cosmetic rules
Guides to US cosmetic requirements: FDA label rules from 21 CFR part 701, MoCRA facility registration and product listing under FD&C Act §607–§608, and the cosmetic-or-drug line that claims draw. Every figure cites the eCFR section or FDA page it comes from; anything we could not verify against the primary source is marked as unverified rather than guessed.
US rules2026/11/10
“Treats acne”: the claim that turns your cosmetic into a drug
In the US, a product intended to treat or prevent acne — or any disease, or to affect the structure or function of the body — is a drug under FD&C Act §201(g), whatever its ingredients. The claim on the label decides, not the formula.
US rules2026/11/10
Cosmetic or drug in the US: how FDA decides
FDA classifies a product by intended use: cleanse and beautify is a cosmetic; treat, prevent disease, or affect body structure or function is a drug (FD&C Act §201). The claims you make decide the category.
EU rules2026/11/10
CPNP vs FDA: what each registration actually asks for
The EU's CPNP notification (Article 13) and the FDA's facility registration and product listing (FD&C Act §607/§608) are different filings, made by different parties, at different times. One does not substitute for the other.
US rules2026/11/10
Is hydroquinone legal in US cosmetics?
Hydroquinone is not on FDA's cosmetics prohibited list, but there is no OTC monograph for it either: FDA treats skin-lightening hydroquinone products as unapproved drugs and has warned that its safety concerns extend to cosmetic use. What the FDA actually says.
US rules2026/11/10
Do ingredients under 1% have to be listed in order?
Both the US and the EU allow a two-block layout: ingredients above 1% in descending order, then everything at 1% or less in any order, then color additives. But the under-1% block cannot float anywhere in the list. The rule text, side by side.
Ingredient guides2026/11/10
Is phenoxyethanol safe in skincare?
What the 1% EU cap does and does not tell you about phenoxyethanol safety, how the US regulates it, and which questions a formulator should ask before raising the dose.
US rules2026/11/10
Who needs to register a facility under MoCRA?
Manufacturers and processors of cosmetics distributed in the US must register each facility with FDA and renew every two years from the initial registration date. Small businesses can be exempt, with four product carve-outs. How Cosmetics Direct, FEI numbers and renewals work.
US rules2026/11/10
MoCRA label requirements for cosmetics
What MoCRA puts on a US cosmetic label, what it puts in a filing instead, and which parts are still waiting on FDA regulations. Responsible person, professional-use statement, adverse-event contact, registration and listing.
US rules2026/11/10
MoCRA product listing: what you file and who files it
Under MoCRA, each cosmetic marketed in the US must be listed with FDA (FD&C Act §608): product category, ingredients, and label copy, filed by the responsible person whose name is on the label. Facility registration (§607) is the companion duty.
US rules2026/11/10
Net quantity on US cosmetic labels: dual declaration and where it goes
21 CFR 701.13 requires the net quantity of contents on US cosmetic labels — fluid measure for liquids (at 68 °F), avoirdupois weight for solids — and a separate metric statement is allowed; products under the FPLA must carry both US customary and metric units.
US rules2026/11/10
Is salicylic acid a drug in the US?
Salicylic acid is a cosmetic ingredient until the label claims acne treatment. Then it is an OTC drug under 21 CFR 333.310, at 0.5–2%, with Drug Facts. Here is where the line sits and how to label each side.
EU rules2026/11/10
Salicylic acid limits: EU vs US for cosmetics
The EU caps salicylic acid at 3.0%, 2.0% or 0.5% depending on product type (Annex III No 98). The US sets no cosmetic limit but treats acne claims as a drug at 0.5–2%. Side-by-side table and label rules.