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Selling it

What federal law requires on the label

By Dwight Davis, Founder

Updated

On this page5

Cosmetic labeling is prescriptive in a way that surprises people arriving from other categories, and the ingredient declaration is the part with the least latitude.

The five elements

A statement of identity, what the product is. The net quantity of contents. The ingredient declaration. The name and place of business of the manufacturer, packer or distributor. And any required warnings, including directions for safe use where they are necessary.

INCI, and why it is not optional

Ingredients are declared in descending order of predominance using INCI names, the International Nomenclature of Cosmetic Ingredients. This is a requirement under the Fair Packaging and Labeling Act and it is not negotiable.

Which means "aloe" is not a declaration and Aloe barbadensis leaf juice is. It also means marketing names, romance names and "natural botanical blend" do not substitute for the list, however much nicer they read.

Ingredients present at one percent or less may be listed in any order after those above one percent, which is the one genuine flexibility in the rule and the reason actives sometimes appear lower than customers expect.

Panel placement

Identity and net quantity go on the principal display panel. The ingredient declaration, the business name and address, and warnings go there or on the information panel.

On a 30 ml bottle this is tight and the ingredient list is usually the longest element, which is why the label panel dimensions belong in the container decision rather than the design decision.

What MoCRA added

Facility registration and product listing, with small-business exemptions, plus adverse event reporting and record keeping.

What it did not add an exemption to is safety substantiation, which applies at every size. And the exemptions fall away entirely for products that are also drugs.

References

US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.gov
Fair Packaging and Labeling Act, and INCI nomenclature for ingredient declaration in descending order of predominance.
Written from published standards and peer-reviewed work, not from a laboratory of our own. Your own challenge and stability results, your supplier's specifications and a qualified safety assessment override anything general said here. Nothing on this site is a safety substantiation.