Review the business name and address on a U.S. cosmetic label

Map the business roles first

1. Identify the manufacturer: record the legal entity and facility that manufactures or processes the finished cosmetic.
2. Identify packers and distributors: document each entity that packs or distributes the product and the contractual role claimed on the artwork.
3. Select the label declaration: compare the proposed name and qualifying wording with the facts rather than copying another SKU.
4. Verify the place of business: preserve the address evidence and any basis used to omit information permitted by the current rule.
5. Connect MoCRA records: reconcile the label identity with the responsible-person, facility-registration, product-listing, and adverse-event records that apply to the product.

Review the final declaration

21 CFR 701.12 addresses the name and place of business of the manufacturer, packer, or distributor. When the named business is not the manufacturer, qualifying wording such as “Manufactured for” or “Distributed by” may be needed to avoid misrepresenting the role. Review the complete declaration for accuracy, prominence, and placement on the label.

• Use the correct legal or operating business identity for the documented role.
• Check that role wording agrees with manufacturing and distribution records.
• Confirm the street address, city, state, and ZIP information against the current rule and reliable directory evidence.
• Keep phone, email, or website contact details separate from the required place-of-business analysis.
• Rerun the review after a distributor, contract manufacturer, address, or responsible-person change.

Why a website or trademark is not enough

A URL can help consumers reach a business, but it does not automatically replace the declaration required by 21 CFR 701.12. A trademark can also belong to an entity different from the manufacturer or distributor. Preserve corporate records, agreements, directory evidence, and the approved label version so the declaration remains traceable.

Official sources

• 21 CFR 701.12 — Name and place of business
• FDA Cosmetics Labeling Guide
• FDA MoCRA overview

Continue the cosmetic label review