FDA Cosmetic Labeling Requirements: What Your Beauty Brand Needs to Know

The U.S. cosmetics market is projected to exceed $100 billion by 2026, and every product sold — from moisturizers and serums to shampoos and lipsticks — must comply with FDA labeling requirements. The passage of the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022 introduced significant new obligations for cosmetic companies, including facility registration, product listing, and adverse event reporting. At CoreXponent, we design cosmetic labels that meet every current requirement so your beauty brand launches clean and stays that way.

FDA Authority over Cosmetics: FD&C Act and MoCRA 2022

Cosmetics are regulated under the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA defines a cosmetic as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Unlike drugs, cosmetics do not require FDA pre-market approval — but their labels must comply with the Fair Packaging and Labeling Act (FPLA) and the FD&C Act's misbranding provisions.

MoCRA, signed into law on December 29, 2022, is the most significant expansion of FDA cosmetic authority in decades. It requires cosmetic manufacturers and processors to register their facilities with the FDA, list their products and ingredients, report serious adverse events, and maintain safety substantiation records. While MoCRA does not change the fundamental labeling requirements, it increases the likelihood that the FDA will scrutinize labels as part of its expanded oversight activities.

Required Cosmetic Label Elements

Product Identity

The principal display panel must show the common or usual name of the product — or an appropriately descriptive name if no common name exists — along with an accurate statement of the product's nature or use (e.g., "moisturizing cream," "body wash," "lip color"). The name must be in a type size reasonably related to the most prominent printed matter on the panel.

Net Quantity of Contents

The net quantity must appear on the lower 30 percent of the PDP in both metric and U.S. customary units (e.g., "3.4 fl oz (100 mL)"). The minimum type size depends on the area of the PDP as specified in 21 CFR 701.13.

Ingredient Declaration

Under 21 CFR 701.3, cosmetics must list all ingredients on the information panel (the panel immediately to the right of the PDP, as displayed to the consumer). Ingredients must be listed in descending order of predominance, with certain exceptions:

• Ingredients present at 1 percent or less may be listed in any order after the last ingredient present at more than 1 percent.
• Color additives may be listed in any order after the non-color ingredients, preceded by the phrase "May contain" or "+/−" if the product is sold in multiple shades.
• Fragrance and flavor ingredients may be listed as "fragrance" or "flavor" without naming individual components.

INCI Names

The FDA requires ingredients to be listed using the names established by the International Nomenclature of Cosmetic Ingredients (INCI) dictionary, maintained by the Personal Care Products Council. Deviating from the INCI nomenclature — for example, using the marketing name "Vitamin C" instead of the INCI name "Ascorbic Acid" — can render the label non-compliant. Botanical ingredients must use the Latin binomial name followed by the plant part and preparation type (e.g., "Aloe Barbadensis Leaf Juice").

Distributor Information

The label must include the name and address of the manufacturer, packer, or distributor. If the company named is not the manufacturer, a qualifying phrase — "Distributed by," "Manufactured for," or "Imported by" — is required. The address must include the city, state, and ZIP code.

Warning Statements

Certain cosmetic products carry mandatory warning requirements:

• Products not adequately tested for safety must bear the statement: "Warning — The safety of this product has not been determined."
• Aerosol products must include appropriate warnings about flammability and intentional misuse.
• Products containing alpha-hydroxy acids (AHAs) at certain concentrations should include a sunburn alert warning per FDA guidance.
• Coal-tar hair dyes containing certain ingredients must include a caution statement and patch test instructions.

The Drug-Cosmetic Distinction: When a Cosmetic Becomes a Drug

This is the single most consequential labeling issue for beauty brands. Under the FD&C Act, a product is a drug if it is intended to diagnose, cure, mitigate, treat, or prevent disease, or if it is intended to affect the structure or any function of the body. Intent is determined by the claims made on the label, in advertising, or on the product's website.

A moisturizer that claims to "hydrate dry skin" is a cosmetic. The same moisturizer claiming to "reduce wrinkles" or "stimulate collagen production" crosses into drug territory because those claims describe an effect on the body's structure or function. Other common triggers:

• Anti-aging claims: "Reduces fine lines," "firms sagging skin," "boosts cell renewal" — all drug claims.
• Sunscreen claims: Any product that claims to protect against UV rays is an OTC drug subject to the sunscreen monograph (21 CFR Part 352).
• Acne treatment: Products claiming to "treat," "prevent," or "clear" acne are drugs.
• Anti-dandruff: Shampoos claiming to treat dandruff are OTC drugs.
• Skin lightening: Products that claim to lighten skin beyond mere cosmetic coverage are drugs.

Products that qualify as both a cosmetic and a drug — commonly called cosmeceuticals in the industry, though the FDA does not recognize this term — must comply with both cosmetic and drug labeling requirements. This includes a Drug Facts panel, active ingredient declaration, indications, directions for use, and OTC drug warnings.

OTC Drug Labeling for Cosmetic-Drug Products

If your product is classified as an OTC drug (sunscreen, anti-acne, anti-dandruff, antiperspirant), the label must include a Drug Facts panel formatted according to 21 CFR 201.66. This panel must include:

• Active ingredient(s) with the established name and concentration.
• Purpose of each active ingredient (e.g., "Sunscreen").
• Uses (indications) — the conditions or symptoms the product is intended to address.
• Warnings — including "For external use only," allergen warnings, and specific warnings required by the applicable OTC monograph.
• Directions for safe and effective use.
• Inactive ingredients listed in alphabetical order.

Skincare Brand Labeling Best Practices

Beyond the legal minimums, these are the labeling practices that CoreXponent recommends for every skincare and beauty brand:

• Audit every claim. Before any claim goes on a label, website, or social media post, classify it as a cosmetic claim or a drug claim. If it's a drug claim, either remove it or reformulate the product to comply with the relevant OTC monograph.
• Use INCI names consistently. Cross-reference your ingredient list with the INCI dictionary and your contract manufacturer's certificate of analysis to ensure names match.
• Include batch and lot codes. While not strictly required by the FD&C Act for cosmetics, batch codes are essential for recall management and are required under MoCRA's adverse event reporting provisions.
• Include a period-after-opening (PAO) symbol. The open jar icon with a number of months (e.g., 12M) is not required in the U.S. but is expected by informed consumers and required if you plan to sell in the EU.
• Consider cruelty-free and vegan certifications. These are not FDA-regulated but are valuable brand signals. Ensure any certification logos on the label are backed by actual certification from the relevant organization.

How CoreXponent Designs Compliant Cosmetic Labels

At CoreXponent, we treat compliance as a design constraint, not an afterthought. Our process for cosmetic label design starts with a full review of your product formula, intended claims, and target market. We then classify the product as a cosmetic, a drug, or both — and design the label accordingly. Every ingredient is verified against the INCI dictionary, every claim is reviewed for regulatory permissibility, and every file is prepared to your manufacturer's print specifications.

Whether you are launching a single SKU or an entire skincare line, CoreXponent delivers labels that are compliant, cohesive, and built to compete.