5 Cosmetics Labeling Mistakes That Trigger FDA Action

With MoCRA granting FDA expanded authority over cosmetics, the agency is paying closer attention to cosmetic product labeling than ever before. In 2025 and early 2026, FDA issued dozens of warning letters to cosmetics companies for labeling violations that were long overlooked.

These are not obscure technicalities. They are straightforward requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) that many companies still get wrong. Here are the five biggest offenders and how to fix them.

Mistake 1: Missing or Incorrect Ingredient Lists

The FD&C Act requires that cosmetic products bear a complete list of ingredients in descending order of predominance. Ingredients must be listed using their International Nomenclature of Cosmetic Ingredients (INCI) names. Many companies make the mistake of using marketing names, chemical names, or abbreviated names instead of the standardized INCI nomenclature.

Another frequent error is listing ingredients in the wrong order. Ingredients present at 1% or less concentration can be listed in any order after the 1% threshold, but ingredients above 1% must be in descending order by weight.

How to Fix It

• Use the International Cosmetic Ingredient Dictionary (ICID) to verify INCI names for every ingredient
• Obtain accurate formulation percentages from your manufacturer to ensure correct ordering
• List fragrance sub-ingredients as "fragrance" or "parfum" (individual allergen disclosure may be required under future MoCRA rulemaking)
• Use our labeling reviewer tool to check your ingredient list formatting

Mistake 2: Unapproved Drug Claims

This is perhaps the most dangerous labeling mistake because it can reclassify your product from a cosmetic to a drug. Under the FD&C Act, a product's classification depends on its intended use. If your labeling claims that a product diagnoses, cures, mitigates, treats, or prevents a disease or affects the structure or function of the body, FDA considers it a drug regardless of what is inside.

The consequences of unintentional drug claims are severe: your product becomes an unapproved new drug subject to enforcement action, including warning letters, seizure, and injunctions.

How to Fix It

• Review all label language, marketing materials, and website copy for implied or explicit drug claims
• Replace structure/function claims with permissible cosmetic claims (e.g., "moisturizes skin" instead of "heals dry skin")
• Train marketing teams on the distinction between cosmetic and drug claims
• If you want to make therapeutic claims, explore whether your product should be registered as an OTC drug

Mistake 3: Missing Net Quantity Statements

The Fair Packaging and Labeling Act requires that the net quantity of contents be prominently placed on the principal display panel (PDP) of the label. The statement must be in both metric and US customary units, and the type size must meet minimum requirements based on the area of the PDP.

Small and indie cosmetics brands frequently get this wrong, either by placing the net quantity on the back of the package (it must be on the PDP), using a font that is too small, or listing only metric or only US customary units.

How to Fix It

• Place the net quantity statement on the lower 30% of the principal display panel
• Include both metric and US customary units (e.g., "50 mL / 1.7 fl oz")
• Verify minimum type size requirements based on your package size
• Do not include any other text between the net quantity and the bottom of the PDP

Mistake 4: No Distributor or Manufacturer Info

Every cosmetic product must bear the name and place of business of the manufacturer, packer, or distributor. The address must include the street address, city, state, and zip code (the street address can be omitted only if the company is listed in a current city or telephone directory).

If the product is not manufactured by the company whose name appears on the label, the name must be qualified with "Manufactured for," "Distributed by," or a similar phrase. Social media handles, email addresses, or website URLs are not substitutes for a physical business address.

How to Fix It

• Include the full business name and physical address on every product label
• Use "Distributed by" or "Manufactured for" if you are not the manufacturer
• A website URL can supplement but never replace the required physical address

Mistake 5: Missing Warning Statements

Certain cosmetic products must carry specific warning statements mandated by FDA regulations. The most common required warnings include:

• Untested products: "Warning: The safety of this product has not been determined" is required unless adequate safety substantiation exists
• Aerosol products: Specific flammability and misuse warnings are required for pressurized containers
• Coal tar hair dyes: Must include a caution statement and directions for preliminary patch testing
• Feminine deodorant sprays: Specific warning language required by regulation
• Products for children: Additional safety warnings may be required depending on the product type

Under MoCRA, the safety substantiation requirement has taken on new importance. If you cannot demonstrate adequate safety data, the warning statement becomes mandatory rather than optional.

How to Fix These Issues

Addressing cosmetics labeling compliance does not have to be overwhelming. Here is a systematic approach:

1. Audit your current labels: Review every product currently on the market against the five requirements above. Use our free labeling reviewer for an automated check.
2. Prioritize by risk: Fix drug claims first (highest enforcement risk), then ingredient lists, then warning statements, then net quantity and address issues.
3. Update your label templates: Create master templates that include all required elements in the correct locations and sizes.
4. Train your team: Ensure product development, marketing, and quality teams understand labeling requirements before new products launch.
5. Implement review processes: No label should go to print without a regulatory review. Build this into your product development workflow.

For more on MoCRA requirements, visit our cosmetics compliance hub or read the MoCRA compliance guide.