Selling it

What the label must carry, in each of the three cases

Updated October 2026

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Three labels for one product Exempt soap A cosmetic A drug References

A consequential page in this property, because the determination you made earlier decides which of three labels is the legal one.

Three labels for one product

The same bar, unchanged, carries a different label depending on how it is represented.

Which is unusual: in most crafts the label follows the formula. Here the label and the marketing are part of what sets the category.

Get the category first, then this page tells you what goes on the package.

Exempt soap

Outside FDA's cosmetic authority, and a consumer commodity, so the Fair Packaging and Labeling Act requirements apply: a statement of identity, a net quantity of contents, and the name and place of business of the manufacturer, packer or distributor.

No ingredient declaration is required.

And CPSC is the agency with jurisdiction, including the Federal Hazardous Substances Act where a product contains a hazardous substance.

It is the lightest of the three labels, and it is available only if both parts of the exemption hold.

A cosmetic

Everything above, plus an ingredient declaration in descending order of predominance using INCI names, plus any required warning statements.

And under MoCRA, facility registration and product listing obligations, with small business exemptions that have to be read against your own numbers rather than assumed.

This is the label most handmade soap actually needs, because most handmade soap is marketed with at least one cosmetic claim.

A drug

A different label entirely: a Drug Facts panel, an active ingredient statement, and compliance with the applicable monograph or an approved application.

Plus drug facility registration and drug listing, and the manufacturing requirements that go with it.

Which is why the practical advice throughout this property is to avoid the claim rather than to build the label, unless you are deliberately making a drug.

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

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

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 Consumer Product Safety Commission. Soap Business Guidance. Products meeting the FDA soap exemption fall to CPSC rather than FDA, with labeling under the Fair Packaging and Labeling Act and the Federal Hazardous Substances Act where relevant. cpsc.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

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.