Cosmetic labeling requirements under the FDA, answered

Questions about cosmetic label compliance

What must a cosmetic label show in the US?

The identity of the product (21 CFR 701.11) and the net quantity of contents (21 CFR 701.13) on the principal display panel; the name and place of business (21 CFR 701.12), the ingredient declaration (21 CFR 701.3) and any required warnings (21 CFR Part 740). MoCRA adds a domestic address, phone number or electronic contact for adverse event reports.

How must cosmetic ingredients be listed?

In descending order of predominance; ingredients at 1 percent or less, and color additives, may follow in any order (21 CFR 701.3). In the EU the ingredient list follows the same principle under Article 19(1)(g) of Regulation (EC) No 1223/2009.

What does an EU cosmetic label need?

The responsible person's name and address, nominal content, the date of minimum durability or the period after opening, precautions, the batch number, the function unless clear from the presentation, and the ingredient list (Regulation (EC) No 1223/2009, Article 19(1)).

Do fragrance allergens have to be named?

In the EU, yes: the fragrance allergens listed in Annex III of Regulation (EC) No 1223/2009 must be named once they exceed 0.001 percent in leave-on or 0.01 percent in rinse-off products. In the US, MoCRA directs FDA to set fragrance allergen labeling rules; until a final rule, fragrance may be declared as "fragrance" (21 CFR 701.3).