FDA Cosmetic Labeling Requirements: What Must Appear on the Label

FDA COMPLIANCE · COSMETICS

Updated November 2026. Beauty brands selling on Amazon, TikTok Shop, Walmart and Shopify are asked for compliant labels more often than for certificates. This guide covers what must appear on a U.S. cosmetic label, how claims change the category, how MoCRA connects to labeling, and how Eva Commerce can help with label review before you print or list. It is general information, not legal advice.

What are FDA cosmetic labeling requirements?

FDA regulates cosmetic labeling under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. A cosmetic is a product, other than soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. The Cosmetics Labeling Guide walks through principal display panel and information panel rules, ingredient declaration, warnings and common mistakes.

Required information must appear prominently and conspicuously so ordinary buyers can read and understand it under normal purchase and use conditions. Putting required text on a bottom panel that shoppers never see at purchase is a classic failure. Our FDA compliance services page covers cosmetics under MoCRA alongside label review.

What must appear on the principal display panel?

The principal display panel (PDP) is the part of the label most likely to be displayed at retail. For cosmetics, FDA expects:

• an identity statement that describes the nature and use of the product, such as “moisturizing cream” or “shampoo”; and
• a net quantity of contents declaration in both U.S. customary and metric units when the Fair Packaging and Labeling Act applies, placed in the bottom 30 percent of the PDP.

Brand names and logos can share the PDP, but they cannot bury or replace the identity or net quantity. Outer cartons that consumers see before opening must carry the same required PDP elements as the immediate container when those cartons are the retail package.

What must appear on the information panel?

The information panel typically carries:

• the name and place of business of the manufacturer, packer or distributor;
• an ingredient declaration, listing ingredients in descending order of predominance, using the names FDA accepts (often INCI names);
• any material warning statements required for the product type; and
• directions for safe use when needed to prevent a health hazard.

Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the label. That name should match the company that lists the product with FDA. Our answer on whether a cosmetic responsible person is the same as a U.S. Agent separates those roles.

How do claims turn a cosmetic into a drug?

Intended use decides the category. FDA says labeling, advertising, internet copy and consumer perception can all establish intended use. A moisturizer that claims to hydrate skin is generally a cosmetic. A cream that claims to treat eczema, restore collagen production or regenerate cells is treated as a drug, or sometimes as a device, even if it is sold next to cosmetics.

FDA does not pre-approve cosmetic claims and does not publish an approved claims list. Labels must still be truthful. Terms such as “hypoallergenic,” “organic,” “cruelty free” and “cosmeceutical” are not FDA-defined seals. Marketplace bullets and A+ content that promise disease treatment create the same category problem as the physical label. For sunscreens, acne treatments and anti-dandruff products that are OTC drugs, see our draft guide on how to get an NDC number for an OTC product.

How does MoCRA connect to cosmetic labeling?

MoCRA added facility registration and product listing duties. Product listing includes ingredients and names the facilities that manufacture or process the product. The ingredient list in Cosmetics Direct should match the label. A reformulation that changes ingredients requires both a label update and a listing update. Facility registration is $440 every two years through Eva, and product listing is $100 per product, one-time, with updates included for the same product. Details are on the MoCRA section of our services page and in our draft on MoCRA product listing in Cosmetics Direct.

What warning statements do cosmetics need?

FDA requires a warning when it is necessary or appropriate to prevent a health hazard associated with the product. Some product types have specific required language, such as certain aerosol and foaming products. Lettering must be bold, on a contrasting background, and at least 1/16 inch high. If a company has not adequately substantiated the safety of a cosmetic, the label must say that the safety of the product has not been determined. Missing a needed warning can make the product misbranded.

Common cosmetic labeling mistakes for online sellers

• Ingredient lists that do not match the current formula or the MoCRA listing.
• Net quantity missing, in the wrong place, or without metric units where required.
• Business name on the label that does not match the responsible person who lists the product.
• Disease or structure/function drug claims on a product still filed only as a cosmetic.
• Marketplace copy that goes further than the physical label.
• Treating a MoCRA listing number as proof that FDA reviewed the label.

How should ecommerce brands check a label before print?

Build a one-page checklist from the final formula and artwork. Confirm the identity statement matches how you will sell the product. Confirm net quantity placement on the principal display panel. Confirm the business name matches the responsible person who will list the product under MoCRA. Confirm every ingredient name on the label matches the listing file. Confirm warnings are present, bold and large enough. Then review marketplace bullets and images against the same claims. Eva’s full compliance label review ($590 per label) is built for that pass before a print run or a first Amazon shipment.

If a contract manufacturer supplies artwork, still verify the responsible person name. Private label brands often leave the manufacturer’s name on the label by mistake, which conflicts with MoCRA listing and with how shoppers identify the brand.

What Eva Commerce charges for cosmetic label review

Eva Commerce offers basic formatting label review at $340 per label and full compliance label review at $590 per label. MoCRA facility registration is $440 every two years. MoCRA product listing is $100 per product, one-time. U.S. Agent service for foreign cosmetic facilities is $250 per year. All prices are published on our FDA compliance services page. Because Eva also manages Amazon, TikTok Shop, Walmart and Shopify, reviewed label facts can inform listing copy so catalog claims stay aligned. Book a call or call 858-315-2020 to review a label before print.

Frequently asked questions

Does FDA approve cosmetic labels before sale?

No. FDA does not pre-approve cosmetic labeling. Labels must still meet the FD&C Act and Fair Packaging and Labeling Act rules and must be truthful and not misleading.

What has to be on a U.S. cosmetic label?

At minimum, identity and net quantity on the principal display panel, plus the business name and place, ingredient declaration when required, and any needed warnings on the information panel.

Can a cosmetic claim to treat acne or wrinkles by changing the skin?

Claims to treat disease or to affect the structure or function of the body generally make the product a drug (or sometimes a device), which follows drug or device rules, not MoCRA cosmetic listing alone.

Do outer cartons need the same labeling as the jar or bottle?

When an outer carton is the retail package consumers see at purchase, it must carry the required principal display panel and information elements.

How does MoCRA product listing relate to the ingredient list?

The responsible person lists each marketed cosmetic, including ingredients. Those ingredients should match the label. Reformulations require listing and label updates.

How much does Eva charge for cosmetic label review?

Basic formatting review is $340 per label. Full compliance review is $590 per label. MoCRA product listing is $100 per product, one-time.

Sources: FDA, Cosmetics Labeling; FDA, Cosmetics Labeling Guide; FDA, Cosmetics Labeling Claims; FDA, Is It a Cosmetic, a Drug, or Both?; FDA, MoCRA overview. General information, not legal advice.

Related Eva guides: FDA compliance services, Responsible person vs U.S. Agent, MoCRA product listing, FDA registration and U.S. Agent guide.