What does MoCRA require on a cosmetic label?

Under FD&C Act § 609(a) and (c), MoCRA (the Modernization of Cosmetics Regulation Act of 2022) adds two requirements to a US cosmetic label. Since 29 December 2024, the label must give a domestic address, domestic phone number or electronic contact (which may be a website) for adverse event reports. A product intended only for licensed professionals must also carry a clear and prominent statement saying so. Everything else on the label still comes from the Fair Packaging and Labeling Act (FPLA) and 21 CFR Part 701 (cosmetic labeling) and Part 740 (cosmetic warning statements). MoCRA's other duties, including registration, listing, safety substantiation and adverse event reporting, never appear on the label.

Two columns: what is printed, and what is not

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, was enacted on 29 December 2022 (Pub. L. 117-328). It added sections 604 to 614 to the FD&C Act, and only § 609 concerns the label. A MoCRA review is therefore best done in two columns: what the artwork must carry, and duties that cannot be confirmed from the artwork alone.

What MoCRA adds to the label

The adverse-event contact

Under FD&C Act § 609(a) (21 U.S.C. 364e(a)), each cosmetic product must bear a label that includes "a domestic address, domestic phone number, or electronic contact information, which may include a website". The responsible person (MoCRA) must be able to receive adverse event reports for that product through this contact.

• Any one of the three is enough. A US address, a US phone number or electronic contact information (such as a website) each satisfies § 609(a).
• "Domestic" qualifies the address and the phone number. A foreign address and foreign phone number alone do not comply.
• Compliance date: 29 December 2024, two years after enactment. A label without the contact is misbranded under FD&C Act § 602(b)(3). No FDA enforcement-discretion policy for § 609(a) has been found; FDA's six-month enforcement discretion covered only registration and listing.

The cosmetic rule differs from the dietary supplement rule: a dietary supplement label must give a domestic address or phone number, and a website alone is not enough.

The professional-use statement

FD&C Act § 609(c) applies to a cosmetic product "intended to be used only by a professional." A professional is an individual licensed by an official State authority to practice cosmetology, nail care, barbering or esthetics. The label of such a product must:

• contain "a clear and prominent statement that the product shall be administered or used only by licensed professionals"; and
• otherwise conform to FDA's cosmetic labeling requirements under the FD&C Act and to section 4(a) of the FPLA (15 U.S.C. 1453(a)).

The statute sets no separate delayed date for § 609(c). The misbranding provision that enforces it, § 602(b)(3), took effect on 29 December 2023.

Fragrance allergens: a watch item, not yet a requirement

FD&C Act § 609(b) requires each fragrance allergen to be identified on the label, once FDA has decided by regulation which substances count. FDA must consider EU requirements, may set thresholds, and had until 29 June 2024 to propose the rule.

Until a final rule takes effect, 21 CFR 701.3(a) still allows "fragrance". Artwork may be planned for allergen disclosure in advance, but this should not be treated as a current federal requirement.

The core label elements: FPLA and 21 CFR Parts 701 and 740

MoCRA replaced none of the existing cosmetic labeling rules. Together with the two MoCRA items above, this table is the full label checklist.

How the ingredient list may be ordered

The default is descending order of predominance (21 CFR 701.3(a)). Section 701.3(f) allows a grouped alternative, in this order:

1. Ingredients other than color additives above 1%, in descending order.
2. Ingredients other than color additives at or below 1%, in any order.
3. Color additives, in any order.

• Fragrance and flavor may be declared as "fragrance" or "flavor"; an unnamed ingredient that is both is declared under each function (701.3(a)).
• Trade secrets. Only where FDA has accepted an ingredient as exempt from disclosure under 21 CFR 720.8(a) may the list end with "and other ingredients" (701.3(a)). The 720.8 procedure was built around the now-closed Voluntary Cosmetic Registration Program; confirm with FDA before relying on it.
• Shaded products. Color additives in only some shades or batches may follow "may contain" (701.3(g)).

Warning statements in Part 740

The obligations that leave no trace on a label

None of these MoCRA duties can be confirmed from a label.

Small business exemption (registration and listing). FD&C Act § 612 (21 U.S.C. 364h) exempts a small business from § 607, the registration and listing section, and also from the § 606 GMP requirements. A small business has average gross annual US cosmetic sales below USD 1,000,000 over the previous three years, adjusted for inflation. The exemption does not apply to anyone who manufactures or processes products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual, products that are injected, products intended for internal use, or products that alter appearance for more than 24 hours where removal by the consumer is not part of customary use. It never exempts anyone from the label requirements.

MoCRA deadlines that have passed

Common mistakes

How RegaaS checks this

For a US cosmetic label, RegaaS applies two instruments (rule set reviewed 10 September 2026):

• FPLA, 21 CFR Parts 701 and 740: statement of identity, net quantity of contents, name and place of business, the ingredient declaration and the names it must use (including the 1% grouping, color additives, fragrance and flavor, and "and other ingredients"), and the mandatory warning statements.
• MoCRA: the adverse-event contact and the professional-use statement on the label. Fragrance allergen labeling is raised as a watch item, not as a finding, because the FDA rule does not yet exist.

Facility registration, product listing, safety substantiation, good manufacturing practice and adverse event reporting are returned as a separate checklist for the responsible person to confirm. Every finding cites its provision, is marked on the label image and carries suggested replacement text.

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

What this guide does not cover

• Sunscreens and other drug–cosmetics. These are OTC drugs (a cosmetic using sun-protection terms generally becomes one), labeled under the drug rules; FD&C Act § 613 exempts them from several MoCRA sections, including § 609(a). RegaaS reports them as out of scope.
• Whether ingredients and color additives are permitted. This guide covers how to declare them, not whether they may be used.
• FTC advertising substantiation and state requirements, including California Proposition 65 and state ingredient disclosure laws. RegaaS reports these as out of scope.
• Other markets. EU labeling is covered in a separate guide; Great Britain and Switzerland are outside RegaaS coverage.

A RegaaS report is a documented review against the provisions above. It is not legal advice, and it does not replace sign-off by a qualified regulatory professional or by the responsible person.

Frequently asked questions

What does MoCRA add to a cosmetic label? A domestic address, domestic phone number or electronic contact for adverse event reports, required since 29 December 2024, and a licensed-professionals-only statement on professional products (FD&C Act § 609(a), (c)).

Is a website enough as the MoCRA adverse-event contact? Yes, for a cosmetic: § 609(a) allows electronic contact information, "which may include a website". A dietary supplement label, by contrast, needs a domestic address or phone number.

Do I have to list fragrance allergens on US cosmetic labels now? Not under federal law yet. Section 609(b) depends on an FDA rule, but no proposed rule has been published yet (planned date November 2026); until a final rule applies, "fragrance" remains permitted under 21 CFR 701.3(a).

Does the small business exemption cover labeling? No. Section 612 exempts qualifying small businesses from registration and listing (and from GMP requirements), but not from § 609 or the Part 701 and 740 label rules.

Do I need to print an FDA registration or listing number on the label? No. Registration and listing are FDA filings under § 607.

Are sunscreens covered by these cosmetic label rules? No. Sunscreens are OTC drugs labeled under the drug regulations, and RegaaS reports them as out of scope.

Primary sources

• FD&C Act § 609 — Labeling (21 U.S.C. 364e)
• FD&C Act § 602 — Misbranded cosmetics (21 U.S.C. 362)
• FD&C Act §§ 605–613 (21 U.S.C. 364a–364i), starting at § 605
• FPLA § 4 (15 U.S.C. 1453)
• 21 CFR Part 701 — Cosmetic labeling (eCFR)
• 21 CFR Part 740 — Cosmetic product warning statements (eCFR)
• 21 CFR Part 720 — Voluntary filing of cosmetic product ingredient composition statements, incl. § 720.8 (eCFR)
• FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• FDA — Registration and Listing of Cosmetic Product Facilities and Products (notes that FDA stopped accepting VCRP submissions on 27 March 2023)
• FDA — Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
• Unified Agenda — Disclosure of Fragrance Allergens in Cosmetic Labeling, RIN 0910-AI90
• Unified Agenda — Good Manufacturing Practice for Cosmetic Product Facilities, RIN 0910-AJ00