MoCRA label requirements for cosmetics

Short answer: a US cosmetic label needs the responsible person’s name and address, the net quantity, the ingredient statement, and — since MoCRA — a domestic contact for adverse-event reports; professional-use products also need “For Professional Use Only” (FD&C Act §609(a); 21 CFR 701.3, 701.12, 701.13).

Label vs filing

MoCRA mixes two kinds of obligation. Some items print on the label; others live in FDA’s systems or in your records.

Requirement	Where it goes	Legal hook
Responsible person name and address	Label, information panel	FD&C Act §609(a); 21 CFR 701.12
“For Professional Use Only”, if applicable	Label	FD&C Act §609(a)
Domestic address, phone or email for adverse-event reports	Label	FD&C Act §609(a)
Product identity and net quantity (dual units)	Principal display panel	21 CFR 701.11, 701.13; 16 CFR 500.8
Ingredient statement, descending order	Information panel	21 CFR 701.3
Facility registration, renewed every 2 years	FDA system	MoCRA §607
Product listing with ingredients, updated annually	FDA system	MoCRA §607
Serious adverse event reports, 15 business days	FDA submission	MoCRA §605
Safety substantiation records	Your files	MoCRA §608

An easy way to remember it: the label carries who is responsible and how to reach them; the filing carries what the product is and where it is made; the records carry why it is safe.

The label in order

Principal display panel: product identity, net quantity in both US customary and metric units, for example Net Wt 1.7 oz (48 g).
Information panel: ingredient statement, name and address of the responsible person, adverse-event contact, warnings, and country of origin for imports.
Professional use: the statement “For Professional Use Only” when the product is sold that way.

Two formatting rules that still trip people up: ingredient letters are at least 1/16 inch high (1/32 inch when the labelling surface is under 12 square inches, 21 CFR 701.3(b), (p)), and the ingredient order is descending — or the 21 CFR 701.3(f) layout: above 1% descending, then 1% or less in any order, then colour additives.

Small business exemption

MoCRA exempts certain small businesses from GMP, registration and product listing. The exemption does not apply to products that:

regularly contact the mucus membrane of the eye,
are injected,
are intended for internal use,
are intended to alter appearance for more than 24 hours where removal is not part of normal use.

The label duties above are not the same as the registration exemption. Check your product category before assuming the whole chapter is optional.

Still moving

As of the FDA MoCRA overview page current to 2026-10-29, FDA is still required to establish regulations for fragrance allergen labelling and for GMP, and has issued draft or proposed documents rather than a final fragrance-allergen rule. We could not verify a final rule on that page today, so do not build a label around a fragrance-allergen list you saw in a blog post. Check the FDA MoCRA page before you print.

Common mistakes

Printing a P.O. box with no street address where 21 CFR 701.12 expects one.
Listing the manufacturer when the brand is the distributor, without “Distributed by”.
Filing the product listing once and never updating ingredients.
Assuming a small-business exemption covers the label requirements.
Using only ounces, or only grams, on the principal display panel.

Sources

FDA, Modernization of Cosmetics Regulation Act of 2022 — overview, current 2026-10-29
FD&C Act §609, cosmetic labelling — 21 U.S.C. 364e
21 CFR 701.3, 701.12, 701.13 — eCFR, issue 2026-11-06
16 CFR 500.8, dual declaration of quantity — eCFR
FDA, Summary of Cosmetics Labeling Requirements — current 2025-11-18

Last verified: 2026-11-10. The fragrance-allergen and GMP rulemaking status is marked unverified; check the FDA page before relying on it.

Not legal advice, and not a guarantee of compliance or of FDA acceptance.

Want this checked against your own formula? Run the free label check. It returns an issue list and a draft ingredient statement, not a print-ready label.