Cosmetic Labeling Requirements: FDA Rules, MoCRA, and Warnings

Cosmetic labeling requirements in the United States are set by the FDA under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, and since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), every retail cosmetic label must carry the product’s identity, net quantity of contents, the name and address of the manufacturer, packer, or distributor, a full ingredient declaration, any warnings that apply to the product category, and contact information consumers can use to report adverse events.¹ Miss any of these and the product is misbranded, which makes it illegal to ship across state lines.

The Core Label Elements

Three pieces of information have to appear on every cosmetic sold at retail, and they are the first things the FDA looks at.

The identity statement tells the consumer what the product is. It can be the common name (“Face Cleanser,” “Body Lotion”) or a description of the product’s nature and use. It belongs on the front of the package.¹

The net quantity of contents states how much product is in the package, expressed in both U.S. customary units (ounces or fluid ounces) and metric units (grams or milliliters). It also belongs on the front.¹

The name and place of business identifies the manufacturer, packer, or distributor by name along with city, state, and ZIP code. The street address can be dropped if the business is listed in a current telephone or city directory.²

One thing that isn’t required: an expiration date. The FDA treats shelf-life determination as the manufacturer’s responsibility rather than a labeling mandate. That changes only if the product also qualifies as a drug, which is discussed further down.³

Ingredient Declaration

Ingredients must be listed by their common or usual names, in English. The FDA has explicitly rejected Latin-only botanical names, EU “CI” color numbers, and terms like “Aqua” or “Parfum” as stand-ins for “Water” and “Fragrance.”⁴

The default order is descending predominance: the ingredient with the highest concentration comes first. The regulation also permits a grouping method that most manufacturers use in practice:⁵

Ingredients other than color additives present above 1%, listed in descending order of predominance.
Ingredients other than color additives present at 1% or less, which may appear in any order after the above-1% group.
Color additives, listed last, in any order regardless of concentration.

Fragrance and flavor compounds get a shortcut. Rather than name each chemical in the blend, a manufacturer can list “fragrance” or “flavor.” An ingredient that plays both roles must be identified by each function it performs. That shortcut is about to narrow: MoCRA now requires disclosure of fragrance allergens on the label, and the FDA is developing a proposed rule expected in 2026 that will specify which allergens and what concentration thresholds trigger the disclosure.⁵⁶

What MoCRA Added to the Label

MoCRA added three items to what the FD&C Act and FPLA had long required.

Adverse event contact information. The label must give consumers a way to report reactions: a U.S. address, phone number, or electronic contact.⁶

Fragrance allergen identification. Each fragrance allergen in the product will need to be named on the label once the FDA’s rule takes effect. Until the rule is final, the general MoCRA obligation still applies, but the specifics of which allergens to disclose and at what thresholds are pending.⁶

Professional-use marking. Products meant only for licensed professionals such as estheticians, cosmetologists, and salon workers must be clearly labeled as professional-use products.⁶

Where Each Piece Goes on the Package

Required information is split between two areas. The Principal Display Panel (PDP) is the portion most likely to be seen at retail. It carries the identity statement and the net quantity of contents.¹

The Information Panel — usually immediately to the right of the PDP, or on the back or side — carries the ingredient list, the business name and address, required warnings, and the MoCRA adverse event contact. Everything has to meet legibility standards: adequate contrast against the background and minimum type sizes. Federal regulations generally specify a minimum type height of 1/16 of an inch for certain required statements, though the exact requirement varies with the information and the package size.⁷

Required Warning Statements

Some categories of cosmetics have to carry specific warnings whose wording is dictated by regulation. The text isn’t customizable.

A cosmetic whose safety hasn’t been adequately substantiated must display, on the PDP: “Warning — The safety of this product has not been determined.”⁸
Aerosol cosmetics must warn against spraying in the eyes and against puncturing, incinerating, or storing the container above 120°F. If the propellant contains a halocarbon or hydrocarbon, a second warning about intentional inhalation is required.⁸
Feminine deodorant sprays must carry a caution specifying external use only, a minimum spray distance of 8 inches from the skin, and instructions to stop use if irritation develops. Using the word “hygiene” or “hygienic” on a feminine deodorant spray makes the product misbranded.⁸
Coal-tar hair dyes get a specific exemption from the adulteration rules for poisonous substances, but only if the label carries a caution about skin irritation and warns against use on eyelashes or eyebrows.⁹

When the Product Is Also a Drug

Sunscreens, antiperspirants, anti-dandruff shampoos, fluoride toothpastes, and anti-acne cleansers are cosmetics and drugs at the same time. Their labels have to satisfy both sets of rules.

Sunscreens show what that means in practice. In addition to the standard cosmetic elements, a sunscreen must carry a Drug Facts panel listing active ingredients, uses, warnings, and directions. The PDP must state the SPF value. “Broad spectrum” claims require a specific UV-A/UV-B testing protocol, and water-resistance claims require their own testing, with label language that differs depending on whether the product retains SPF after 40 or 80 minutes in water.¹⁰

Drug products, including dual-use cosmetics, must carry expiration dates supported by stability testing. That obligation does not apply to standalone cosmetics.³

Claims That Cross the Line

What a label says about a product decides how it’s regulated. A cosmetic is defined by its intended use: cleansing, beautifying, promoting attractiveness, or altering appearance. A drug is intended to diagnose, cure, treat, or prevent disease, or to affect the body’s structure or function.¹¹¹²

A moisturizer marketed for “softer skin” is a cosmetic. The same product marketed to “treat eczema” is a drug. Describing a lotion as something that “stimulates cell regeneration” or “reduces wrinkle depth” crosses into drug territory and reclassifies the product as an unapproved new drug subject to much stricter regulation.¹³

“Organic” Is a USDA Term, Not an FDA One

The FDA does not define or regulate “organic” for cosmetics. That authority belongs to the USDA under the National Organic Program. To display the USDA Organic seal, agricultural ingredients must meet NOP production, handling, and processing standards, and every entity in the supply chain must be certified by a USDA-accredited certifying agent.¹⁴ USDA recognizes four labeling tiers:¹⁵

100 Percent Organic — every ingredient is organic (excluding salt and water); may display the USDA Organic seal.
Organic — at least 95% organic ingredients; may display the USDA Organic seal.
Made with Organic [ingredient] — at least 70% organic ingredients; no USDA seal, and the label may name up to three specific organic ingredients or ingredient categories.
Products with less than 70% organic content may identify individual certified organic ingredients within the ingredient list but may not use “organic” on the front of the package or display the seal.

“Natural” Has No Federal Definition

“Natural” is not defined for cosmetics at the federal level. One narrow related policy: as of early 2025, the FDA exercises enforcement discretion to allow “no artificial colors” claims on products that avoid petroleum-based colors, even if they contain colors derived from natural sources. Previously, such a claim was permitted only if the product contained no added color at all.¹⁶

What Happens If the Label Is Wrong

A cosmetic that fails the labeling rules is “misbranded” under the FD&C Act. The statute defines misbranding broadly: labeling that is false or misleading in any way, failure to include the business name and address, failure to state the net quantity of contents, or failure to comply with the labeling requirements set out in MoCRA’s Section 609.¹⁷ A misbranded product cannot legally enter interstate commerce.

Enforcement tools include warning letters demanding corrective action, product seizures, injunctions against continued sale, and mandatory recalls. MoCRA gave the FDA recall authority for the first time: if the agency finds a reasonable probability that an adulterated or misbranded cosmetic will cause serious adverse health consequences or death, and the responsible person refuses to recall voluntarily, the FDA can order the recall.¹⁸ Warning letters are published publicly on the FDA’s website.¹⁹

1
Food and Drug Administration. Summary of Cosmetics Labeling Requirements
2
eCFR. 21 CFR 701.12 – Name and Place of Business of Manufacturer, Packer, or Distributor
3
Food and Drug Administration. Shelf Life and Expiration Dating of Cosmetics
4
Food and Drug Administration. Cosmetic Ingredient Names
5
eCFR. 21 CFR 701.3 – Designation of Ingredients
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Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
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eCFR. 21 CFR Part 701 – Cosmetic Labeling
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eCFR. 21 CFR Part 740 – Cosmetic Product Warning Statements
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GovInfo. 21 USC 361 – Adulterated Cosmetics
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eCFR. 21 CFR Part 352 – Sunscreen Drug Products for Over-the-Counter Human Use
11
Food and Drug Administration. Cosmetics and U.S. Law
12
Office of the Law Revision Counsel. 21 USC 321 – Definitions; Generally
13
Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
14
Agricultural Marketing Service. Cosmetics, Body Care, and Personal Care Products
15
Agricultural Marketing Service. Labeling Organic Products
16
Food and Drug Administration. FDA Takes New Approach to “No Artificial Colors” Claims
17
Office of the Law Revision Counsel. 21 USC 362 – Misbranded Cosmetics
18
Food and Drug Administration. FDA Recall Policy for Cosmetics
19
Food and Drug Administration. Warning Letters Related to Cosmetics