Yes. Cosmetics distributed in the United States must comply with applicable FDA labeling requirements under the FD&C Act, the Fair Packaging and Labeling Act, and regulations including 21 CFR Parts 701 and 740. Imported cosmetics are subject to the same U.S. requirements as domestically produced cosmetics.

Requirements vary with the product and package, but common elements include a statement of identity and net quantity on the principal display panel; the name and place of business of the manufacturer, packer, or distributor; an ingredient declaration for retail consumer cosmetics; any required warning statements; and the MoCRA contact information through which the responsible person can receive adverse event reports.

FDA regulations require ingredients to be identified by names established or adopted by regulation or by appropriate common or usual names under 21 CFR 701.3. Industry INCI terminology is often useful, but FDA does not accept every international or Latin-only name as a substitute for the U.S.-accepted ingredient name. For example, FDA states that terms such as Aqua or Parfum may accompany, but should not replace, Water or Fragrance.

No. FDA does not pre-approve cosmetic product labeling before marketing. The manufacturer or distributor is responsible for making sure the cosmetic and its labeling comply with applicable law. Color additives are an important exception because they must be permitted for their intended uses, and some are subject to batch certification.

The principal display panel is the part of the label most likely to be displayed or examined under customary conditions of sale. For cosmetics, the PDP generally carries the statement of identity and an accurate net quantity declaration in the form and placement required by 21 CFR Part 701.

Claims that a product treats or prevents disease or affects the structure or function of the body can cause the product to be regulated as a drug, even when it is marketed as a cosmetic. Claims in labeling, websites, advertising, and other promotional materials can be evidence of intended use.

MoCRA added section 609 of the FD&C Act. Each cosmetic product must bear a domestic address, domestic phone number, or electronic contact information, such as a website, through which the responsible person can receive adverse event reports. MoCRA also directs FDA to establish fragrance-allergen labeling requirements by regulation and includes labeling requirements for professional-use cosmetics.

Not necessarily. Two different requirements should be separated. The existing name-and-place-of-business rule under 21 CFR 701.12 applies to the manufacturer, packer, or distributor. MoCRA section 609(a) separately requires a domestic address, domestic phone number, or electronic contact information through which the responsible person can receive adverse event reports. A website or other electronic contact can satisfy that MoCRA contact requirement.

The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

For retail consumer cosmetics, ingredients generally are declared in descending order of predominance. Important exceptions apply, including ingredients present at one percent or less and color additives, which may be listed without regard to predominance within the rules of 21 CFR 701.3.

Yes. FDA regulations prohibit or restrict certain cosmetic ingredients and uses, including substances such as bithionol, chloroform, methylene chloride, vinyl chloride in aerosol products, certain mercury compounds, and others. The exact restriction and product use must be checked against current FDA regulations.

A color additive must be permitted by FDA for the specific intended cosmetic use. Some color additives are subject to FDA batch certification, while others are exempt from certification. Eye-area, lip, external-use, and other limitations can differ, so the exact color additive and intended use should be verified.

Yes. Imported cosmetics must comply with the same U.S. labeling laws and regulations that apply to cosmetics produced domestically. Imported products may also have country-of-origin marking obligations administered by U.S. Customs and Border Protection.

It can. Claims made on websites, marketplace listings, social media, and advertising can affect intended-use analysis and regulatory classification. We can review marketing claims when they are included in the agreed scope, while recognizing that advertising is also subject to Federal Trade Commission authority.

Our standard cosmetic label review is generally completed within 2–3 business days after we receive complete label artwork, ingredient information, and the claims to be reviewed. Timing can vary for complex products or incomplete submissions.

Send the complete label artwork or all label panels, the full formula or ingredient list, ingredient concentrations when available, intended product use, target consumer, packaging size, and any website or marketing claims you want included in the review.

Our professional Cosmetic Labeling & Ingredient Review fee is $250 USD per label as a one-time service. It covers the agreed review of one cosmetic product label and ingredient declaration; additional products, major reformulations, or expanded marketing-claim reviews can require additional scope.

No. Label review is a professional compliance service used to evaluate the label, ingredient declaration, claims, warnings, and other requirements. MoCRA product listing is a separate FDA submission made by the responsible person for each covered marketed cosmetic product, with annual listing updates.

No. Facility registration applies to covered cosmetic manufacturing and processing facilities and is renewed every two years. Label review focuses on the product label, ingredients, claims, warnings, and regulatory classification. Product listing is also a separate obligation.

No. MoCRA requires the responsible person to ensure and maintain records supporting adequate substantiation of safety. A label and ingredient review can identify obvious regulatory or ingredient issues, but it does not replace the scientific safety substantiation required for the finished cosmetic product.

A product that meets FDA's narrow regulatory definition of soap and is labeled and marketed solely as soap is regulated by the Consumer Product Safety Commission rather than as a cosmetic by FDA. Cleansers with cosmetic claims or drug claims may instead be regulated as cosmetics, drugs, or both.

Products such as sunscreens, antiperspirants, anti-dandruff shampoos, and acne treatments can be drugs or drug/cosmetic combination products because of their intended uses. Those products must meet applicable drug requirements in addition to cosmetic requirements where relevant.

The term cosmeceutical has no legal meaning under the FD&C Act. A product is regulated according to its intended use and can be a cosmetic, a drug, or both. Drug-like claims can trigger drug regulation regardless of the marketing term used.

These terms require careful review. FDA does not define a general legal standard for terms such as natural or clean in cosmetic labeling, and there is no federal FDA standard that guarantees a cosmetic labeled hypoallergenic is less likely to cause an allergic reaction. Organic claims can also implicate USDA rules depending on how the claim is made.

Under current U.S. ingredient-labeling rules, fragrance or flavor ingredients generally may be declared collectively as Fragrance or Flavor rather than disclosing each component. Trade-secret and ingredient-labeling rules still apply.

MoCRA directs FDA to establish fragrance-allergen labeling requirements and to determine the covered allergens by regulation. FDA continues to identify fragrance-allergen labeling as a rulemaking requirement. Until the applicable regulation specifies the allergens and compliance dates, firms should not assume that an EU fragrance-allergen list automatically equals the current U.S. legal requirement.

Some ingredient-declaration exemptions or alternate methods can apply to free samples, products distributed only for professional or institutional use, or certain small packages. MoCRA also contains specific labeling requirements for cosmetics intended to be used only by professionals. The exact distribution channel and package should be reviewed before relying on an exemption.

Sometimes a shared design is possible, but the required wording and ingredient nomenclature are not automatically interchangeable. FDA does not accept some EU-style ingredient names, such as Latin-only botanical names or CI numbers, as substitutes for U.S.-accepted common or usual names. Other countries also have their own responsible-person, allergen, language, and formatting rules.

Generally, current U.S. federal cosmetic law does not require an expiration date on most cosmetic labels. However, cosmetic firms remain responsible for product safety and for maintaining adequate safety substantiation, and some products or other jurisdictions may have different dating requirements.

A new review is appropriate when the formulation, ingredient names, color additives, package size, net quantity, responsible-person information, domestic adverse-event contact, warnings, intended use, or claims change. A re-review is also useful when a product moves into a different regulatory category or sales channel.