Private label skincare: what it means and the FDA rules that apply

What private label skincare means

Private label skincare is a cleanser, serum, moisturizer or other cosmetic that a contract manufacturer produces and you sell under your own brand. You choose the products, put your brand on the label and sell them to customers.

Three arrangements go by similar names. In private label, the manufacturer makes a product for your brand, usually by adjusting one of its existing base formulas for scent, color or texture. In white label, the manufacturer sells the same finished product to several brands and only the label changes. In custom formulation, a chemist develops a new formula for your brand. These are trade terms, and a quote may use them differently, so ask which one it describes.

Is your private label product a cosmetic or a drug?

Check which category each product falls into before you order, because the rules are different. FDA says whether a product is a cosmetic or a drug is determined by its intended use. A cosmetic is a product applied to the body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

A product intended to affect the way a person’s body works, or to treat or prevent disease, is a drug. One way FDA establishes intended use is through claims on the product labeling, in advertising, on the internet or in other promotional materials, and certain claims may cause a product to be considered a drug, even if it is marketed as a cosmetic. Some products are both. FDA's example is that an antidandruff shampoo is a cosmetic because it cleanses the hair, and also a drug. The same applies to skincare: moisturizers and makeup marketed with sun-protection claims are cosmetic/drug products and must meet the requirements for both.

Drugs sold without a prescription follow separate rules: over-the-counter drugs must carry "Drug Facts" labeling under 21 CFR 201.66, and combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. FDA names acne medications among the nonprescription drug categories covered by OTC monographs. If you want a product to stay a cosmetic, keep its claims to cleansing, beautifying or changing appearance, and leave out claims to treat acne, heal skin or change how the skin works.

Who is responsible when your brand is on the label

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) sets duties for cosmetics companies. It defines the responsible person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. For a private label product, that is normally your company, because your name is on the label. Some duties sit with you and some with the facility that makes the product.

FDA does not set a fixed list of tests: neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. Animal testing is not a requirement for marketing a cosmetic product.

FDA cosmetics labeling basics for a private label product

A manufacturer's stock label may not match your product name, size or claims, so check every line before you print. FDA regulates cosmetics labeling under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These are the core items for a skincare product sold at retail.

• A statement of identity, which says what the product is, and the net quantity of contents. FDA says the identity statement must appear on the principal display panel, which FDA defines as that part of a panel that is most likely to be shown or examined under customary conditions of display for retail sale. On the outer container the net quantity goes within the bottom 30% of the principal display panel, and the bottom placement rule is waived for panels of 5 square inches or less.
• An ingredient list in descending order of predominance. Under the alternative grouping FDA allows, ingredients other than color additives present at not more than 1 percent can follow without respect to order. Scent ingredients can be grouped: fragrance or flavor may be listed as fragrance or flavor. MoCRA adds a separate duty: the responsible person must identify on the label each fragrance allergen in the product. Which substances count as fragrance allergens is determined by the Secretary of Health and Human Services by regulation, so check FDA's cosmetics pages for the status of that rule.
• The name and place of business of the company on the label. If that is your brand and not the manufacturer, the name must be qualified by a phrase such as “Manufactured for” or “Distributed by”. FDA notes that a post office box or website address is not adequate for the name and place of business.
• A contact for adverse event reports: the label must include a domestic address, domestic phone number, or electronic contact information through which the responsible person receives adverse event reports.
• Warning statements where needed: the label must bear a warning statement whenever necessary or appropriate to prevent a health hazard, in type no less than 1/16 inch unless a regulation sets a smaller size.
• English for every required statement: all statements required by law or regulation must be in English.

Color additives have their own rule: a color additive must be approved by FDA for the intended use. Ask the manufacturer to confirm that each color in the formula is approved for its use. Words such as natural or organic do not change the rules: the same requirements for safety and labeling apply to all cosmetics, no matter what their source. Origin claims are handled by another agency: the Federal Trade Commission regulates claims of "Made in USA".

The small business exemption and what it does not cover

Small brands get some relief under MoCRA. Qualifying small businesses are not subject to the good manufacturing practice (section 364b) or registration and listing (section 364c) requirements. A small business here means a responsible person or facility with average gross annual US sales of cosmetic products under $1,000,000 for the previous 3-year period, adjusted for inflation.

The exemption does not apply to a business that makes or processes certain products, and two of the listed exclusions can reach skincare. It excludes products that regularly come into contact with mucus membrane of the eye. If a product is used close to the eye, check whether this applies before you rely on the exemption. It also excludes products intended to alter appearance for more than 24 hours where removal by the consumer is not part of normal use.

The exemption names only good manufacturing practice and registration and listing. It does not mention the serious adverse event reports, safety records or label contact described above, so plan for those duties even as a small brand.

A regulatory checklist for a private label skincare launch

These steps cover the regulatory side of a private label launch. They do not name manufacturers.

1. Decide the products and the claims

   List every claim you plan to make on the label, your website and your ads, and check each one against the cosmetic and drug definitions above. A claim to treat or prevent disease moves the product into drug rules.

2. Shortlist manufacturers and ask the same questions

   Ask each one whether its facility is registered with FDA under MoCRA, what safety data it can share for each formula, who owns the formula, the minimum order and the lead time. Get the answers in writing.

3. Collect the safety file

   Ask for the safety data behind each formula and keep it under your brand, since the responsible person holds the safety records. FDA will not point you to a lab: FDA does not recommend private laboratories to consumers or manufacturers for sample analysis.

4. Write the label

   Cover each label item listed above, and have the manufacturer confirm in writing that the ingredient list matches the formula.

5. List the products and set up reporting

   Unless the small business exemption applies, list each product with FDA. Set up the contact you print on the label and a process for serious adverse event reports.

6. Check state and city rules

   Ask the state and local authorities where you operate about licensing and other requirements, and check the rules in the states you ship to.

State rules and the limits of this guide

This page covers federal rules for cosmetics sold in the US. Rules vary by state and city: FDA does not license cosmetics firms, but state or local authorities may require licensing or have other requirements. Business registration, sales tax and permits also depend on where you operate.

This page is general information, not legal or regulatory advice. For a specific product, read FDA's own cosmetics pages, send MoCRA questions to FDA at QuestionsAboutMoCRA@fda.hhs.gov, or talk to a lawyer who works with cosmetics companies.

Where Nation fits

Questions about private label skincare