Body Care
Soaps, balms and scrubs are cosmetics: labeling and safety substantiation under MoCRA.
Federal Rules Apply$1MSmall-business line
3 yrsAvg sales test
AlwaysAdverse event reports
NameResponsible person label
What is covered and what needs a different path
What this guide covers
- Lotions, balms, scrubs and lip care
- Cosmetic soaps made for skin cleansing
- Bath salts and bath bombs sold as cosmetics
- Hair and beard oils with cosmetic claims only
Needs a different path
- True soap with drug claims such as acne or eczema treatment
- Sunscreen and anti-dandruff products (OTC drugs)
- Products for the eye area or injected use (no small-business relief)
- Making health claims without clearance
Three compliance steps
A
Check the exemption
Businesses with average annual U.S. cosmetic sales under $1 million over 3 years are exempt from facility registration and product listing, but not from safety or labeling.
B
Substantiate safety
Keep documentation that each product is safe, plus fragrance allergen and preservative review.
C
Label and report
Ingredient list in descending order, net quantity, responsible-person name and address, and U.S. contact for adverse event reports.
Quick reference
| Item | Rule | Regulator |
|---|---|---|
| Facility registration | Exempt for small businesses under $1M average sales | FDA (MoCRA) |
| Safety substantiation | Required for every cosmetic | FDA |
| Ingredient label | INCI names, descending order | FDA; FPLA |
| Adverse events | Report serious events within 15 business days | FDA |
| Drug claims | Treating a condition makes it a drug | FDA |
Frequently asked questions
Does MoCRA apply to me?Yes, even if you are a small business. You skip registration and listing, not the safety and labeling duties.
Is cold-process soap a cosmetic?Only if it makes cosmetic claims such as cleansing and fragrance; true soap has a separate definition.
Do I need a state permit?Massachusetts has no general cosmetics permit; check local business licensing.
Printable checklist
- Sales average confirmed under $1M
- Safety substantiation file complete
- INCI ingredient list on label
- Net quantity on label
- Responsible-person address on label
- Adverse event process written
- No drug claims in marketing