Contents

Makeup, skincare, haircare, nails, and fragrance: what the words on the package are legally allowed to mean, what the ingredient list is actually telling you, and how long the thing in your hand stays safe to use.

FDA's own framing is that people use 6 to 12 cosmetic products a day — makeup, nail polish, shaving cream, perfume, cleansers, haircare, moisturisers. This section starts from the rules because almost every consumer question about cosmetics ("is this tested?", "why is this banned in Europe?", "when do I throw it out?") turns out to be a question about which rule book the product falls under.

Every cosmetic product

252 product types in twelve categories, every one of them with a page. The spine is FDA's own cosmetic product category list — the seventeen primary categories used for registration and listing under MoCRA, current to 11 February 2026, which restate the thirteen categories of 21 CFR 720.4(c). Under each regulatory bucket sit the product types actually sold, including the modern ones the 1974 list buries in "other".

Two things the list is not. It is not a list of brands. And it is not only a list of cosmetics: sunscreen, anticaries toothpaste, antiperspirant, antidandruff shampoo and diaper cream are drugs as well, and are marked where they appear.

Skincare

45 products. Cleansing, exfoliating, toning, treating, moisturising and masking, plus the body, hand, foot and lip preparations that fall under the same regulatory heading.

Makeup

40 products. Everything applied for colour and coverage — face, eyes, brows and lips — plus the two categories FDA carves out for children.

Haircare

33 products. Washing, conditioning, treating and styling — everything done to hair that does not change its colour.

Hair Colour

18 products. Dyes, tints, deposits, lighteners and removers, plus the eyelash and eyebrow dyes the coal-tar exemption does not reach.

Nails

18 products. Polish and its systems, extensions, the care products for nail and cuticle, and what takes it all back off.

Fragrance

11 products. The concentration ladder, the forms it is sold in, and the scented powders that share the regulatory heading.

Bath and Body

19 products. Washing, soaking, the underarm, and the intimate-care products FDA files under personal cleanliness.

Shaving and Hair Removal

21 products. Before the razor, after the razor, the beard, and the chemical and wax routes that skip the razor entirely.

Oral Care

9 products. Dentifrices, whitening, and rinses — the shortest category here, and the one where the cosmetic/drug line runs straight through the aisle.

Sun and Tanning

18 products. Sunscreen, after-sun, the tanning preparations FDA does regulate as cosmetics, and the sunless routes.

Baby

11 products. The washing, skin and wipe products FDA files separately because they go on infants.

Tattoo and Body Art

9 products. Inks, plant dyes, aftercare and the glitter that sits alongside them.

Not on the list

Brushes, sponges, tweezers, lash curlers and the rest of the toolkit are not cosmetics. Nothing is applied to the body from them that is itself a product, so they fall outside both the FD&C Act definition and Regulation (EC) No 1223/2009. Nor are soap that is true soap, dietary supplements sold as "beauty from within", or the injectables and devices used in a clinic — those are drugs, food, or medical devices.

What counts as a cosmetic

The category is defined by intended use, not by chemistry or by where it is sold. The two definitions that matter:

Definition
United States "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance" — FD&C Act, sec. 201(i). Soap is expressly excluded.
European Union "any substance or mixture intended to be placed in contact with the external parts of the human body…or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours" — Regulation (EC) No 1223/2009, Art. 2(1)(a). Anything ingested, inhaled, injected or implanted is excluded by Art. 2(2).

Cross that line into treating or preventing disease, or affecting the structure or function of the body, and the product is a drug as well — FD&C Act sec. 201(g). That is not a technicality; it changes the entire rule set. Products that are both:

  • sunscreen, and any makeup or moisturiser carrying an SPF number
  • anticaries ("fluoride") toothpaste
  • antiperspirants that are also deodorants
  • antidandruff shampoo

Those must meet drug requirements too, including stability testing and a printed expiration date.

The United States rule set

There is no premarket approval. Cosmetic products and ingredients do not need FDA clearance before they go on sale — the sole exception being colour additives, which are permitted only if FDA has approved them for that use, and some of which may only be used from batches FDA has tested and certified. The manufacturer carries the legal responsibility for safety and labelling, and FDA acts after the fact.

The two failure modes the law names are adulteration (composition — a poisonous or deleterious substance, filth, insanitary preparation, an unsafe colour additive; sec. 601) and misbranding (labelling that is false or misleading, missing required information, or a deceptively filled container; sec. 602).

What must be on the label
  • Ingredients in descending order of predominance, on any information panel, letters no smaller than 1/16 inch (1/32 inch if the package surface is under 12 square inches) — 21 CFR 701.3.
  • Ingredients present at 1 percent or less may be listed in any order, and so may colour additives.
  • Trade-secret ingredients accepted by FDA as exempt may be hidden behind "and other ingredients".
  • Where a cosmetic is also a drug, the active ingredients come first, labelled as such.
  • The ingredient declaration is an FPLA requirement and applies to retail sale only. Professional-use, institutional-use, free samples and hotel amenities are exempt — which is why the bottle in a salon back room may carry nothing.
  • A product whose safety has not been adequately substantiated must carry "Warning—The safety of this product has not been determined" (21 CFR 740.10) or risk being treated as misbranded.

The short prohibited list

FDA regulation specifically prohibits or restricts eleven entries, which is the whole of the named list: bithionol, chlorofluorocarbon propellants, chloroform, halogenated salicylanilides, hexachlorophene (capped at 0.1% and only where nothing else works), mercury compounds (eye-area only, ≤65 ppm, and only if no other safe preservative exists), methylene chloride, prohibited cattle materials, "sunscreen" wording, vinyl chloride in aerosols, and zirconium-containing complexes in aerosols.

Two of those eleven are not really bans — the sunscreen entry is a classification rule, and the cattle-materials entry is a BSE control. The list is short by design: it is the set FDA has affirmatively regulated, not a positive list of what is allowed. The general prohibition on any ingredient that makes a product harmful in normal use applies whether or not the ingredient appears here.

The coal-tar hair dye carve-out is the strangest survival in the statute. FDA cannot act against a coal-tar hair dye on safety grounds so long as the label carries this exact caution and patch-test directions:

Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do may cause blindness.

The exemption does not extend to eyelash and eyebrow dyes. Every dye used in those must be FDA-approved for that use.

What MoCRA changed

The Modernization of Cosmetics Regulation Act of 2022 is the largest expansion of FDA's cosmetics authority since the FD&C Act of 1938. It does not create premarket approval; it creates visibility and a recall power.

Obligation Detail
Facility registration Manufacturers and processors register with FDA, renewing every two years. FDA may suspend a registration where products have a reasonable probability of causing serious adverse health consequences or death.
Product listing The responsible person — the manufacturer, packer or distributor named on the label — lists each marketed product including its ingredients, updated annually.
Safety substantiation Records supporting adequate safety substantiation must be kept. No specific test is mandated, and animal testing is not required to market a product.
Serious adverse events Reportable to FDA within 15 business days, with a copy of the retail label; new information received within a year of the first report goes in within another 15 business days.
Mandatory recall Where a product is adulterated or misbranded and will cause serious adverse health consequences or death, FDA can order a recall if the responsible person will not do it voluntarily.
Records access FDA can access and copy certain records, safety records included.

MoCRA also directs FDA to write rules for Good Manufacturing Practice, fragrance allergen labelling, and standardised asbestos testing for talc-containing products — the talc proposed rule issued December 2024 and was withdrawn in November 2025, so that one is unsettled. The required PFAS report was published 29 December 2025.

Small businesses are exempt from GMP, registration and listing — but not if they make products that regularly contact the mucous membrane of the eye, are injected, are for internal use, or are intended to alter appearance for more than 24 hours without consumer removal.

The European Union rule set

The EU inverts the American default. Instead of a short prohibited list plus a general safety duty, it runs one long prohibited list and positive lists for the three ingredient classes that do the most damage when they go wrong. In the consolidated text current to 1 May 2026:

Annex Covers Runs to reference number
II Prohibited substances 1,766
III Restricted substances (conditions of use) —
IV Permitted colorants 153
V Permitted preservatives 60
VI Permitted UV filters 34

Annexes IV, V and VI are closed lists: a colorant, preservative or UV filter that is not on them cannot be used at all. Article 15 separately bans CMR substances — carcinogenic, mutagenic or toxic for reproduction — of categories 1A, 1B and 2, with narrow, evaluated exceptions.

Three more differences a reader will actually notice:

  • Notification, not approval. Before placing a product on the market the responsible person notifies the Commission electronically (Art. 13) — product category and name, where the product information file is kept, country of origin, nanomaterials present, and any category 1A/1B CMR substances.
  • Animal testing is banned outright (Art. 18) — both performing the tests in the EU and marketing products tested that way. The deadline was 11 March 2009 for most endpoints and 11 March 2013 for repeated-dose toxicity, reproductive toxicity and toxicokinetics.
  • Dating is mandatory (Art. 19(1)(c)). Products with a minimum durability of 30 months or less carry a "best used before the end of" date. Products lasting longer carry a period-after-opening figure instead, shown as the open-jar symbol with a number of months. Nanomaterials must be flagged "(nano)" in the ingredient list, fragrance appears as "parfum" or "aroma", and shade ranges may pool their colorants behind "may contain" or "+/-".

FDA's own explanation of the divergence is procedural rather than scientific: under US law the burden is on FDA to prove an ingredient harmful, and it cannot compel manufacturers to hand over their safety data. It may take another country's decision into account, but can only act inside its own framework.

Label claims with no legal meaning

Three terms appear constantly and none of them is defined by FDA.

"Hypoallergenic" — "The term means whatever a particular company wants it to mean." There is no federal standard, and no obligation to substantiate the claim. FDA wrote a rule requiring comparative testing in 1975; Almay and Clinique challenged it, and the DC Circuit struck it down in 1977 on the ground that FDA had not shown consumers understood the term the way the rule defined it. Nothing has replaced it since. FDA also states it knows of no scientific studies showing that products making the claim cause fewer adverse reactions than conventional ones.

"Organic" — not defined in the FD&C Act, the FPLA, or any regulation FDA enforces. USDA's National Organic Program owns the term, and a cosmetic making the claim has to satisfy USDA for the claim and FDA for safety and labelling. FDA is blunt about the implication: an ingredient's source does not determine its safety, and plenty of plants are toxic or allergenic whether or not they were grown organically.

"Cruelty-free" / "Not tested on animals" — no legal definition, so use is unrestricted. The common shapes the claim takes: applying it only to the finished product while suppliers or contract labs do the animal testing, or resting it on raw materials that were tested on animals decades ago and are simply not being tested now.

The one binding constraint on all three is the general one: labelling must not be false or misleading. Advertising claims, as opposed to label claims, are the FTC's jurisdiction rather than FDA's.

Shelf life, and when to throw it out

No US law requires a cosmetic to carry an expiration date or to have any particular shelf life. FDA treats determining shelf life as the manufacturer's job, and companies are not required to share their stability testing. Products that are also drugs — anything with SPF, acne treatments — must be stability tested under 21 CFR 211 and must print a date.

So the useful dates are the ones the industry volunteers, plus the EU's open-jar symbol, which increasingly appears on products sold in both markets.

What actually degrades a product: fingers introducing bacteria and fungi; preservatives breaking down over time so those organisms can grow; applicators picking up contamination on every use; emulsions separating; bathroom moisture; drying, cracking, and colour and odour changes from heat, sunlight and air.

  • Eye-area products have the shortest lives and the worst failure mode, since a contaminated product can cause serious eye infection. Manufacturers generally recommend discarding mascara two to four months after purchase.
  • Dry mascara goes in the bin. Do not add water, and never saliva.
  • Stop using every eye-area product if an eye infection appears, throw out the ones in use, and see a clinician.
  • Do not share makeup. Store testers are more contaminated than the same product at home; if you must test, use a fresh applicator.
  • Keep containers and applicators clean, and keep products out of heat — a hot car breaks preservatives down and speeds growth.
  • Treat flea-market and resold-online stock with suspicion: past shelf life, already used, diluted, tampered with, or counterfeit.

Elsewhere on the site

Sources

Every figure and quotation above was read from these pages on 16 August 2026.

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