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Everything that has to be on the label

Updated

On this page6

A checklist in three columns, because the same bar carries a different label in each category.

Pick your column first

Run the category check before this page. Building a label for the wrong category is the commonest expensive reprint in the craft.

And remember the label is part of the determination rather than a consequence of it: the words you choose here can move the product between columns.

Exempt soap

Statement of identity. What it is, on the principal display panel. "Soap", or "bar soap".

Net quantity of contents. The cured weight, in both US customary and metric units, in the required placement on the principal display panel.

Name and place of business of the manufacturer, packer or distributor.

No ingredient declaration required.

Plus any warning required where the product contains a hazardous substance, which is the Federal Hazardous Substances Act layer rather than the packaging one.

A cosmetic

All three of the above, plus:

Ingredient declaration in descending order of predominance, using INCI names, on an information panel.

Ingredients at one percent or less may be listed in any order after those above one percent, and color additives may be listed last.

Warning statements where required, and directions where needed for safe use.

Plus the MoCRA obligations that sit behind the label: facility registration, product listing, safety substantiation and adverse event records, subject to the small business exemptions.

A drug

Drug Facts panel in the prescribed format.

Active ingredient and its purpose.

Uses, warnings and directions.

Inactive ingredients.

Plus lot or batch code and an expiry where the applicable requirements call for one, and the drug registration and listing obligations behind it.

A product can be both a drug and a cosmetic, in which case it carries both sets.

Things that go wrong on a real label

The net weight is the cut weight rather than the cured weight.

The ingredient list uses kitchen names rather than INCI, on a product that is a cosmetic.

A cosmetic claim appears in the product name while the label elsewhere is built for exempt soap.

The website says something the wrapper does not, and the exemption is evaluated across all of it.

And the business address is missing, which is the easiest one to leave off and is required.

References

Fair Packaging and Labeling Act, and the consumer commodity requirements: a statement of identity, a net quantity of contents and the name and place of business of the manufacturer, packer or distributor. ftc.gov
US Food and Drug Administration. Cosmetics Labeling Guide, and the cosmetic labeling requirements that apply the moment a product is not exempt soap. fda.gov
INCI nomenclature for cosmetic ingredient declaration in descending order of predominance, which applies to a soap that is a cosmetic and not to exempt soap. fda.gov
US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov
US Food and Drug Administration. Cosmetic versus drug: a product making a therapeutic claim, or offered to treat or prevent a condition, is a drug. fda.gov
Federal Hazardous Substances Act and 16 CFR Part 1500, which reach household products containing hazardous substances — relevant to lye as a raw material and to any product that is not simple soap. ecfr.gov
21 CFR 701.20. FDA interprets "soap" to apply only to articles where the bulk of the non-volatile matter consists of an alkali salt of fatty acids, the detergent properties are due to those alkali-fatty acid compounds, and the product is labeled, sold and represented only as soap. ecfr.gov
Written from the federal regulation and FDA and CPSC guidance named on each page, not from a laboratory or a legal practice. Whether a particular product and a particular label make exempt soap, a cosmetic or a drug is a determination about your product, and this is not that determination.