Cosmetic Labeling Under MoCRA: What Must Appear on Your Label

Existing Labeling Requirements (Pre-MoCRA)

Before MoCRA, cosmetic labeling was governed by the FD&C Act and the Fair Packaging and Labeling Act (FPLA), with regulations codified at 21 CFR Parts 701 and 740. These existing requirements still apply and include:

• Product identity statement: The name of the product and its nature (e.g., "moisturizing cream") on the principal display panel (21 CFR §701.11)
• Net quantity of contents: The amount of product in the container, expressed in weight, measure, or count (21 CFR §701.13)
• Name and place of business: The manufacturer, packer, or distributor's name and address (21 CFR §701.12)
• Ingredient declaration: All ingredients listed in descending order of predominance (21 CFR §701.3)
• Warning statements: Required for products with specific safety concerns (21 CFR Part 740), including the sunscreen warning, aerosol warnings, and warnings for products not adequately tested for safety

New MoCRA Labeling Requirements

MoCRA added several new labeling obligations for cosmetics marketed in the United States:

Adverse Event Contact Information (FD&C Act §609(a))

This is the most significant new labeling requirement. Every cosmetic product label must include contact information that consumers can use to report adverse events. Specifically, the label must include:

• A domestic phone number, or
• An electronic contact (such as an email address or website URL) through which the Responsible Person can receive adverse event reports

This contact information must be on the product label itself — not just on outer packaging. For small containers where space is limited, FDA guidance allows for the information to be provided through alternative means, but the general expectation is that it appears directly on the label.

Responsible Person Identification

While the pre-MoCRA requirement to list the manufacturer, packer, or distributor already existed (21 CFR §701.12), MoCRA codifies that the entity listed on the label is the "Responsible Person" with specific legal obligations for product listing, adverse event reporting, and safety substantiation.

Fragrance Allergen Disclosure (Proposed)

FDA has indicated it will propose regulations requiring specific fragrance allergens to be individually identified on cosmetic labels, rather than grouped under the generic term "fragrance." As of early 2026, this is still in the proposed rulemaking stage (NPRM anticipated mid-2026). When finalized, this will require label updates for any product containing covered allergens.

Safety Substantiation Warning

Under FD&C Act Section 608 (as amended by MoCRA), if a cosmetic product does not have adequate substantiation of safety, its label must bear the following warning:

This warning was already part of 21 CFR §740.10 but is now reinforced by MoCRA. FDA expects all cosmetics companies to have adequate safety data — carrying this warning label is not a viable long-term strategy, as it signals to FDA (and consumers) that the product may not be safe.

Label Compliance Checklist

Use this checklist to verify your cosmetic labels meet all current requirements:

1. Product identity statement on the principal display panel
2. Net quantity of contents in compliant units (metric and/or U.S. customary)
3. Name and place of business of the Responsible Person
4. Complete ingredient declaration in descending order of predominance
5. Adverse event reporting contact information (domestic phone number or electronic contact) — NEW under MoCRA
6. Required warning statements (if applicable — e.g., aerosol products, self-tanning products, professional-use products)
7. Safety substantiation warning if safety data is inadequate
8. All required information in English (bilingual labels are permitted but English is mandatory)
9. Country of origin marking for imported cosmetics (per CBP requirements, 19 CFR Part 134)

Next Steps for Label Compliance

If your cosmetic labels have not been updated since MoCRA took effect, prioritize these actions:

1. Add adverse event reporting contact information to all product labels
2. Verify that the Responsible Person information on your label is accurate and matches your product listing in Cosmetics Direct
3. Review ingredient declarations for completeness and accuracy
4. Prepare for potential fragrance allergen disclosure requirements
5. Ensure safety substantiation documentation exists for every product to avoid the "safety not determined" warning

Assurentry's MoCRA compliance services include labeling reviews, product listing management, and ongoing regulatory monitoring to keep your cosmetics business compliant.