Two layers of label rules now apply
Cosmetic labeling in the U.S. runs on two overlapping frameworks: the long-standing Fair Packaging and Labeling Act (FPLA) and FD&C Act misbranding provisions, and the newer MoCRA additions layered on top. Most of what governed cosmetic labels before 2022 still applies unchanged; MoCRA adds a handful of new, mandatory elements rather than replacing the underlying framework.
What was already required
- Statement of identity — what the product is, on the principal display panel, in terms a consumer understands.
- Net quantity of contents — weight or volume, in both metric and U.S. customary units.
- Name and place of business of the manufacturer, packer, or distributor.
- Ingredient declaration on the information panel, listed in descending order of predominance by weight, using standardized INCI (International Nomenclature of Cosmetic Ingredients) names.
- Warning and caution statements where required for specific product categories (e.g., aerosols, certain hair products).
None of this changed with MoCRA. What changed is what gets added on top, and how seriously FDA can now enforce the whole package.
What MoCRA added
Domestic contact information for adverse events
Since December 29, 2024, labels must include a domestic address, domestic phone number, or electronic contact method (a website or email address) where consumers, retailers, or healthcare providers can report adverse events directly to the Responsible Person. This is a genuinely new mandatory element, not a restatement of the existing "name and place of business" line — it has to function as a live reporting channel.
Professional-use-only statement
Products intended exclusively for use by licensed professionals (salon-only formulations, for example) must be labeled to say so. This matters because it also affects small-business exemption eligibility and how the product is expected to be used and substantiated for safety.
Fragrance allergen disclosure — not yet in force
MoCRA directed FDA to establish a rule requiring disclosure of fragrance allergens above a certain concentration, similar to frameworks already in place in the EU and elsewhere. FDA missed the statutory deadline for this rule. As of this guide, no final rule exists, so listing "fragrance" or "parfum" generically within the ingredient declaration remains acceptable. We recommend maintaining allergen-level formulation records now so you're not starting from zero once the rule lands.
Don't get ahead of the regulation on this one. Voluntarily itemizing fragrance allergens before the rule is final is fine, but there's currently no compliance requirement to do so, and premature itemization can create its own labeling consistency issues if the eventual rule's format differs from what you chose.
Safety substantiation isn't a label element, but it backs one
The Responsible Person's safety substantiation obligation (covered in the Responsible Person guide) doesn't appear as label text, but it's what legally supports every safety-adjacent claim your label makes. A product can be misbranded even with a technically complete label if the substantiation behind its safety and claims doesn't actually exist.
Watch the drug-claim boundary
Label copy that claims a product treats, prevents, or cures a condition, or otherwise affects the structure or function of the body beyond cosmetic effect, can tip a product into being regulated as a drug — a different, more demanding framework entirely. This isn't new to MoCRA, but it's one of the most common labeling mistakes we see cosmetics brands make when marketing copy outruns what the product is actually classified as.