Children's Cosmetics — FDA, CPSC & EU Regulation Guide
Diaper creams, bubble baths, baby washes, and flavored lip balms each carry different regulatory burdens — and two US agencies are watching
Two Agencies, One Product
There is no single set of "children's cosmetic regulations" in the United States — instead, two separate federal agencies divide oversight based on what they each govern. The FDA regulates the formula (is it a cosmetic or a drug?) while the CPSC (Consumer Product Safety Commission) regulates product safety and packaging for anything marketed to children. Both sets of rules can apply to the same product at the same time.
The phrase "marketed to children" is the key trigger for most of these additional requirements. A plain zinc oxide cream sold for adults is a straightforward cosmetic. That same cream in a package with cartoon animals and sold as "baby balm" is now a children's product subject to CPSC oversight on top of FDA rules. Intention and presentation both matter.
FDA Jurisdiction
- • Cosmetic vs. OTC drug classification
- • Ingredient safety and labeling
- • Bubble bath mandatory warning (21 CFR 740.17)
- • OTC drug monograph requirements (diaper rash, SPF)
- • MoCRA facility registration & adverse event reporting
- • Lead action levels in lip products
CPSC Jurisdiction
- • Child-resistant packaging (PPPA)
- • Lead limits in children's product substrates (CPSIA)
- • Phthalate restrictions in childcare articles (CPSIA)
- • Product safety recalls for children's items
- • Labeling requirements under FHSA for hazardous substances
The EU Adds a Third Layer
If you sell into the EU or UK market, EU Cosmetics Regulation 1223/2009 has specific ingredient restrictions that apply only to products intended for children under 3 — including hard prohibitions on certain preservatives in the diaper area. These do not have direct US equivalents but are important for anyone exporting.