Guides / US soap labels
US soap label requirements, explained for makers
Published 26 September 2026; rules last checked 25 September 2026. A labelling reference, not legal advice.
In the US, a soap label starts with one question: is it "true soap" or a cosmetic? True soap, made from fats and lye and sold only as soap, is not regulated by FDA as a cosmetic. Its package needs three things: what the product is, who makes or sells it and where, and the net weight in ounces and grams. An ingredient list is voluntary. Make a cosmetic claim such as "moisturizing", or use a synthetic detergent, and the same bar is a cosmetic: FDA's rules add a full ingredient list, and MoCRA adds a way for customers to report reactions to you.
Step one: true soap or cosmetic?
FDA reads "soap" narrowly. Under 21 CFR 701.20 a product is soap only if both of these hold:
- the bulk of its non-volatile matter is alkali salts of fatty acids, and its cleaning action comes from those salts; and
- it is labelled, sold and represented only as soap.
FDA's own examples of what turns a soap into something else:
- A cosmetic claim. A soap intended to moisturize the skin, make the user smell nice or deodorize is a cosmetic.
- Synthetic detergents. If the product contains synthetic detergents, it is a cosmetic, not a soap. This is the one to check on a melt-and-pour base.
- A drug claim. Killing germs, or treating acne or eczema, makes it a drug (and possibly a cosmetic too), with its own labelling rules that this guide does not cover.
In every case you can still call the product "soap" on the label; what changes is which rules apply. FDA says products that meet its definition of soap are regulated by the Consumer Product Safety Commission, not by FDA.
True soap: what the package must say
A true soap is not a cosmetic, so FDA's cosmetic labelling rules do not apply to it. Its package is labelled under the Fair Packaging and Labeling Act, through the FTC's rules for consumer commodities in 16 CFR Part 500, whose worked examples are soap bars. Three things are required:
- The identity of the product on the principal display panel (the part of the label a shopper sees first), as a principal feature, by its common or usual name, such as "soap" (500.4).
- Your name and place of business: street address, city, state and ZIP code, with "Manufactured for" or "Distributed by" when someone else made the soap. The street address may be left off if it is listed in a publicly available resource such as a directory or a website (500.5).
- The net quantity on the principal display panel, in both ounces and grams, for example "Net Wt 4 oz (113 g)" (500.6 and 500.8). It sits in the bottom 30% of that panel unless the panel is 5 square inches or smaller, set apart from other text, with a minimum letter height that grows with the panel: 1/16 inch up to 5 square inches, 1/8 inch up to 25 (500.21).
An ingredient list is not required on a true soap. You may still print one; the soap tool writes it in the US form and marks it as voluntary.
Cosmetic soap: what FDA's rules add
Once your soap is a cosmetic, 21 CFR Part 701 governs the label:
- Identity on the principal display panel, in bold type (701.11).
- Name and place of business, with the same "Manufactured for" or "Distributed by" wording when someone else made the soap (701.12).
- Net quantity on the principal display panel, by weight for a bar, in ounces; FDA's Cosmetics Labeling Guide says the metric figure may be added (701.13). The same bottom-30%, spacing and letter-height rules apply.
- The ingredient list (701.3): every ingredient in descending order of predominance, although ingredients at 1% or less may follow in any order, with color additives last in any order. Fragrance may be declared simply as "Fragrance". The letters must be at least 1/16 inch high, or 1/32 inch on a package with less than 12 square inches of surface for labels, and the list may go on a firmly attached tag if the package has no room.
- Warnings where Part 740 requires one. A foaming bath product, for example, carries the caution in 740.17 unless it is labelled for adults only.
The names follow US conventions, which differ from the EU's in ways that show on a label. The soap tool prints "Water" where an EU label says "Aqua" and plant oils with the common name in brackets, as in "Olea Europaea (Olive) Fruit Oil", both as FDA's substance registry records them, and "Fragrance" where the EU says "Parfum". Saponified oils read the same in both, such as "Sodium Olivate" and "Sodium Cocoate".
MoCRA: what the 2022 law added
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added three things a cosmetic soap maker should know about:
- A contact for adverse event reports on the label: a US address, a US phone number, or electronic contact information such as a website, through which you can receive reports of reactions. In force since 29 December 2024 (21 U.S.C. 364e(a)).
- Fragrance allergens, not yet. MoCRA requires the fragrance allergens FDA identifies by regulation to be named on the label, and that regulation is not in force yet (364e(b)). Until it is, fragrance stays "Fragrance", with nothing itemised.
- The small-business exemption covers paperwork, not labels. Makers whose average US cosmetic sales over the previous three years are under $1,000,000 a year (adjusted for inflation) are exempt from facility registration, product listing and the good manufacturing practice rules, unless they make products that regularly touch the eye's mucous membrane, injected or internal products, or products meant to change the user's appearance for more than 24 hours. The labelling duties above still apply (364h).
None of this applies to a true soap, which is not a cosmetic.
How a US label differs from an EU one
- In the EU every soap is a cosmetic, so the ingredient list is always required. In the US a true soap needs none.
- The EU names 81 fragrance allergens individually once they pass 0.01% in a soap. The US names none yet.
- The EU label carries a responsible person in the EU and a batch number. The US label carries your name and place of business, and a true soap's net weight in both unit systems.
The EU soap label guide has the European rules in full.
Common questions
Do I have to list ingredients on handmade soap in the US?
Only if it is a cosmetic. A true soap (made from fats and lye, sold only as soap, with no cosmetic claims) is outside FDA's cosmetic rules under 21 CFR 701.20, so an ingredient list is voluntary. A soap with cosmetic claims or synthetic detergents is a cosmetic and needs the full list under 21 CFR 701.3.
Does calling my soap 'moisturizing' change the label?
Yes. FDA treats a soap intended to moisturize the skin, deodorize or make the user smell nice as a cosmetic, so the ingredient list, FDA's identity and net quantity rules and MoCRA's adverse-event contact all apply to it.
Is melt-and-pour soap 'true soap'?
Only if its cleaning comes entirely from alkali salts of fatty acids. FDA says a product containing synthetic detergents is a cosmetic, so read your base's ingredient list: if it contains a synthetic detergent, label the finished soap as a cosmetic.
Do I have to list fragrance allergens on a US soap label?
Not yet. MoCRA (21 U.S.C. 364e(b)) requires fragrance allergens to be named once FDA identifies them by regulation, and that rule is not in force. Until it is, fragrance on a cosmetic's list is declared as 'Fragrance'.
Does the MoCRA small-business exemption cover labels?
No. Businesses with average US cosmetic sales under $1,000,000 a year over the previous three years are exempt from facility registration, product listing and the good manufacturing practice rules (21 U.S.C. 364h), but the labelling duties, including the adverse-event contact, still apply.
Who regulates true soap in the US?
FDA says products that meet its definition of soap are regulated by the Consumer Product Safety Commission, not by FDA. What the package must say comes from the Fair Packaging and Labeling Act, through the FTC's rules in 16 CFR Part 500.
Tell me when this guide goes out of date
The rules here were last checked against the primary texts on 25 September 2026. The change we are watching for is FDA's fragrance-allergen rule under MoCRA: when it lands, cosmetic soap labels in the US will have to name allergens, and we will email you.
No spam, no account. One email when a rule behind your labels changes. How we handle your address is in the privacy policy.
Sources
- 21 CFR Part 701, sections 701.3 (ingredient declaration), 701.10 to 701.13 (principal display panel, identity, name and place of business, net quantity) and 701.20 (soap), eCFR, current to 21 September 2026
- 21 CFR Part 740, section 740.17 (foaming detergent bath products)
- 16 CFR Part 500, sections 500.2 to 500.8 and 500.21, the FTC's regulations under the Fair Packaging and Labeling Act
- 21 U.S.C. 364e (labelling, including the adverse-event contact in force from 29 December 2024) and 364h (small businesses), as added by MoCRA
- FDA, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) and Frequently Asked Questions on Soap; Cosmetics Labeling Guide
- US ingredient names: FDA's Global Substance Registration System (GSRS), INCI records, checked 23 September 2026
The same documents our label engine's rule tables are transcribed from and checked against. A labelling reference, not legal advice; you remain responsible for your product's labelling.