The short answer
The U.S. has no separate approval or registration category for baby or children’s cosmetics. Baby shampoo, baby lotion, baby wipes, kids’ bubble bath, children’s play makeup and face paint follow the same MoCRA rules as any other cosmetic: facility registration, product listing, safety substantiation, a U.S. contact on the label and serious adverse event reporting.
What changes is the risk. Children are the users, so safety records, talc, colors and claims get extra attention. Several common baby claims — “treats diaper rash”, “SPF 50”, “kills lice” — make the product an OTC drug.
Cosmetic or drug? Common baby and kids’ products
| Product / claim | Usually | Why |
|---|---|---|
| Baby shampoo, baby wash, bubble bath | Cosmetic | Cleansing only |
| Baby lotion or oil “moisturizes and softens” | Cosmetic | Appearance and feel of the skin |
| Baby wipes for cleansing | Cosmetic | Cleansing — unless they claim to kill germs |
| Diaper cream “helps treat and prevent diaper rash” | OTC drug | Skin protectant claim under OTC monograph M016 (for example zinc oxide 1–25%) |
| Kids’ sunscreen, lotion “with SPF” | OTC drug | Sunscreen claim — see sunscreen registration |
| Lice shampoo, antibacterial hand gel | Drug | Kills lice or germs |
| Children’s play makeup, face paint, glitter | Cosmetic | Coloring the skin — color additive rules apply |
Five points to check for children’s products
- 1Safety substantiation for the real userMoCRA requires records showing each product is safe under its labeled or customary conditions of use. For a baby product, your safety assessment should reflect that the users are babies or children — skin, amounts used and the chance of swallowing.
- 2TalcBaby powders and kids’ makeup often contain talc. FDA’s testing programs found asbestos in some talc cosmetics in 2019, which led to a baby powder recall. Source talc carefully and keep test results. See talc in cosmetics.
- 3Color additivesFace paints, play makeup, colored bath products and glitter may only use colors FDA permits for that use and area. See color additive rules.
- 4Claims“Hypoallergenic”, “tear-free”, “pediatrician tested” and “gentle” have no FDA definition, so they must be true and supported by your records. Treatment or SPF claims make the product a drug.
- 5LabelsIdentity, net quantity, ingredients in descending order, the responsible company and a U.S. contact for adverse events. Toys or play items packed with a cosmetic may also fall under U.S. Consumer Product Safety Commission rules.
The OTC drug route for diaper creams and kids’ sunscreen
If your product makes a drug claim, it is not listed under MoCRA. Instead the manufacturer needs drug establishment registration, an NDC labeler code, drug listing and a Drug Facts label that follows the monograph. Diaper rash products use the wording “Helps treat and prevent diaper rash” from monograph M016. Sunscreen Drug Facts tell parents of children under 6 months to ask a doctor. See NDC numbers for OTC drugs.
Example: a baby care brand from Germany
A German brand sells baby wash, baby lotion and a zinc oxide diaper cream in the U.S. The wash and lotion are cosmetics: it registers its factory under MoCRA, lists both products, keeps safety assessments written for infant use and adds a U.S. contact to the labels. The diaper cream says “helps treat and prevent diaper rash”, so it goes the OTC drug route — drug establishment registration, NDC, drug listing and a Drug Facts panel with zinc oxide inside the monograph range.
Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). Product listing $150 per product. Cosmetics label review $250. For diaper creams and sunscreens: drug registration, NDC labeler code and U.S. Agent $550, drug listing $350.
Frequently asked questions
Does FDA have special rules for baby cosmetics?
There is no separate category. Baby and children’s cosmetics follow the same MoCRA and labeling rules as other cosmetics, but the safety records should reflect use on babies or children.
Is diaper rash cream a cosmetic?
Not if it claims to treat or prevent diaper rash. That is an OTC skin protectant drug under monograph M016, which needs drug registration, an NDC and a Drug Facts label.
Can I say “hypoallergenic” or “tear-free” on a baby shampoo?
FDA has not defined these terms. You can use them only if they are true and you have evidence to support them.
Are small baby care brands exempt from MoCRA?
Qualifying small businesses may be exempt from registration and listing, but not from safety substantiation, labeling or adverse event reporting. See the small business exemption.
Sources
- FDA — Is it a cosmetic, a drug, or both? (Or is it soap?)
- FDA — OTC Monograph M016, Skin protectant drug products (diaper rash)
- FDA — Talc (updated January 16, 2026)
- 21 U.S.C. 364d — Safety substantiation
Requirements checked on November 11, 2026. This article is general information, not legal advice.