21 CFR 740 Cosmetic Warnings: Aerosols, Hair Dye, Bubble Bath and Tanning Oil

Most cosmetics carry no warning statement, and FDA does not want one invented. A short list of product classes is different: for each of them 21 CFR Part 740 prescribes a statement, sometimes word for word, that must appear on the label. Miss it and the product is misbranded. Amazon's restricted products page for cosmetics prohibits products lacking FDA-required labeling, so a missing caution is also a reason a listing can be removed.

This guide covers each class, the wording, and the two packaging rules that travel with the same products: tamper-resistant packaging for mouthwash and child-resistant packaging under the Poison Prevention Packaging Act.

Which products carry a required warning

Decide the product class first, from the listing text and the images, because the rules attach to the class and not to the ingredient list:

Product class	Rule	Trigger
Aerosol or self-pressurised container	21 CFR 740.11	Hairspray, dry shampoo, mousse, setting spray, body spray, shaving foam in a pressurised can
Foaming detergent bath product	21 CFR 740.17	Bubble bath, foaming bath; stricter wording for children's products
Coal-tar hair dye	21 USC 361(a); 21 CFR 740.18	Permanent, demi- and semi-permanent colour using coal-tar dyes; extra warning if it contains 4-MMPD
Feminine deodorant spray	21 CFR 740.12	Any spray marketed for that use
Suntan or tanning product without sunscreen	21 CFR 740.19	Tanning oil, tan accelerator, bronzing oil with no SPF active

A sixth provision, 21 CFR 740.10, is the catch-all: a cosmetic whose safety has not been adequately substantiated must say so on the label. Under MoCRA that substantiation is now a statutory duty in its own right, covered in our MoCRA guide for Amazon sellers.

Aerosols: 21 CFR 740.11

Every self-pressurised container carries: "Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F. Keep out of reach of children." If the propellant is flammable, add "Do not use near heat or flame."

Two formulation points sit next to the warning. Chlorofluorocarbon propellants are prohibited in cosmetics (21 CFR 700.23) and appear on Amazon's prohibited list in their own right, and zirconium complexes are prohibited in aerosol cosmetics (21 CFR 700.16). Vinyl chloride is likewise prohibited as an aerosol ingredient (21 CFR 700.14). None of those will be in a modern formula, but a listing that mentions them, outside a "free-of" phrasing, will be read as an ingredient disclosure.

Bubble bath: 21 CFR 740.17

Foaming detergent bath products carry: "Caution. Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children." For products for children, the keep-out-of-reach sentence is extended with "except under adult supervision".

Kids' bubble bath is where this most often goes wrong, and it is also where a second regime arrives. A cosmetic designed or intended primarily for children 12 and under is a children's product under 15 USC 2052(a)(2) and 16 CFR 1200, which brings the CPSIA with it: lead limits, the phthalate restrictions in 16 CFR 1307 where the item is a toy or child care article, third-party testing at a CPSC-accepted lab, and a Children's Product Certificate. Play makeup, kids' nail polish and glitter gels are the obvious cases. The listing should state the age grade; a play-makeup kit presented as an ordinary cosmetic with no age statement is a finding on its own.

Coal-tar hair dye: 21 USC 361(a) and 740.18

Coal-tar hair dyes get a specific carve-out in the FD&C Act's cosmetic adulteration section (21 USC 361(a)), and the price of that carve-out is a caution plus patch-test directions. The statutory wording: "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 so may cause blindness." The directions for the preliminary (patch) test must accompany the product.

A dye containing 4-MMPD also carries the 740.18 cancer warning. Separately, note that m- and o-phenylenediamine are on the California AB 2762 list banned from 2025-01-01 and the Washington list, so check the developer and colourant INCI lists against the state bans as well as the federal caution.

The eyelash and eyebrow sentence is not decorative. Amazon's prohibited list names permanent eyelash and eyebrow dyes outright.

Tanning products without sunscreen: 740.19

A suntan, tanning or bronzing product that contains no sunscreen carries: "Warning. This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn."

This is the mirror image of the SPF problem. Add a sunscreen active and the product is an OTC drug under 21 CFR 201.327 and leaves Beauty; leave it out and the 740.19 warning is mandatory. A tanning oil listing that says neither is wrong one way or the other.

Feminine deodorant sprays: 740.12

The required statement: "For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops." If the product is also an aerosol, the 740.11 warning applies as well.

Beyond Part 740: packaging and hazmat for mouthwash and nail products

Two packaging rules are checked on the same label images, and Amazon's own dangerous-goods review follows the same products.

Tamper-resistant packaging (21 CFR 700.25). Liquid oral hygiene products, meaning mouthwash, mouth rinses and breath sprays, and vaginal products must be packaged in a tamper-resistant package with a labeling statement describing the feature, placed so that opening the package does not remove it. "Sealed for your protection" or "Do not use if seal under cap is broken or missing" with a shrink band or inner seal is the usual form. A mouthwash listing whose images show a plain flip-top and whose text never mentions a seal is missing the statement.

Child-resistant packaging (16 CFR 1700.14). The Poison Prevention Packaging Act reaches three kinds of cosmetic:

1. Mouthwash with 3 grams or more of ethanol per package (1700.14(a)(17)). In practice that is any alcohol-containing mouthwash much above a travel size.
2. Liquid products with more than 5% methacrylic acid, which means acid-based nail primers (1700.14(a)(24)).
3. Products with 10% or more low-viscosity hydrocarbons, which can include some nail polish removers, hair oils and baby oils (1700.14(a)(7)).

Packages must pass the testing in 16 CFR 1700.15 and 1700.20, and the test report belongs in your document file. A single package size may be sold without child-resistant packaging if labeled "This package for households without young children", but only one size. Alcohol-free mouthwash and ordinary nail polish are outside the rule.

Amazon hazmat review. The products above overlap heavily with Amazon's dangerous-goods review. Nail polish and removers, perfumes and colognes, hairspray, aftershave and any aerosol are flagged for classification before they can be fulfilled, and Amazon asks for a GHS-format Safety Data Sheet, or an exemption sheet where the formula is not hazardous. The dangerous-goods regulation attribute on the listing drives that review, so a blank or wrong value stalls fulfilment even when the label is perfect. Have the SDS from the manufacturer before the first shipment plan.

Checking your images

The warnings live on the package, so the check is a visual one:

• Identify the class from the title, bullets and images.
• Open every packaging image at full zoom and look for the prescribed statement. Wording may vary slightly; the substance must match.
• For aerosols, confirm the flammable-propellant sentence if the propellant calls for it.
• For children's bubble bath, confirm "except under adult supervision".
• For mouthwash, find the tamper-resistant statement and, if the product contains alcohol, the child-resistant closure.
• For nail primers and removers, check the acid or hydrocarbon content against the PPPA thresholds.
• Confirm the SDS and the dangerous-goods attribute are in place for nail, fragrance and aerosol products.

Verid8 runs this as a vision check: it decides the product class from the listing, reads the label images for the 21 CFR 740 statement, the tamper-resistant line and the closure type, and reports the required wording as the fix when one is missing. The Beauty & Personal Care page lists the rest of the rule set.

The prescribed warnings are short, old and unambiguous. They are also the easiest finding for any reviewer to confirm, because the regulation tells them exactly what to look for.