Body Care

Soaps, lotions, balms & topical skin products

MoCRA Registration Path
MoCRAfederal cosmetic law since 2023
$0for true lye soap (CPSC, not FDA)
$1Msmall-business exemption threshold
13054ISDH manufacturer application form

What's Covered  /  What Needs a Different Path

✓ Covered here

  • True soap made by saponifying oils/fats with lye, sold with no cosmetic claim (regulated as a consumer good, not a cosmetic)
  • Lotions, balms, and scrubs registered as cosmetics under MoCRA facility & product listing
  • Small businesses under roughly $1M in average gross annual sales, with some product exemptions

✗ Needs a different path

  • Any topical product with a drug claim (acne treatment, sunscreen, anti-aging "reduces wrinkles") – becomes an FDA drug
  • Eye-area products and a short list of MoCRA categories excluded from the small-business exemption
  • Selling without responding to an FDA facility registration request if your volume outgrows the exemption

Three Steps to Compliance

A

Sort soap from cosmetic

If it's true soap with no cosmetic claim, it isn't FDA-regulated; if it makes any skin-care claim (moisturizing, exfoliating) it's a cosmetic under MoCRA.

B

Register under MoCRA

Cosmetic manufacturers register their facility and list every product with the FDA; check whether your sales size qualifies for the small-business exemption.

C

File with the state and label fully

Submit ISDH's manufacturer/processor form (State Form 13054) if applicable, and label with ingredients in descending order, net weight, and your business name/address.

Quick Reference

ItemRuleRegulator
True lye soap, no claimsNot FDA-regulated as cosmeticCPSC (federal)
Lotions, balms, scrubsMoCRA facility + product listingFDA (federal)
Small-business exemption~$1M average gross sales threshold, exclusions applyFDA MoCRA
State manufacturer filingForm 13054, Mfr/Processor of CosmeticsIndiana State Dept. of Health

Frequently Asked Questions

Is homemade soap regulated by ISDH?

No, true soap is a CPSC consumer product, not a food or FDA cosmetic, as long as you make no cosmetic or drug claims.

What is MoCRA?

The Modernization of Cosmetics Regulation Act (2022) requires cosmetic makers to register facilities and list products with the FDA, with a small-business exemption for many home sellers.

Can I claim my balm heals eczema?

No – that's a drug claim, which moves your product out of cosmetics and into FDA drug regulation with a much higher compliance bar.

Do I need an Indiana-specific cosmetics license?

Indiana doesn't run a separate cosmetics license, but ISDH's manufacturer/processor form is used by makers who also handle food-adjacent or wholesale distribution.

Printable Checklist

Decide if your product is true soap or a cosmetic
Register your facility with the FDA under MoCRA if required
List every cosmetic product with the FDA
Check your small-business exemption eligibility yearly
Avoid drug-style therapeutic claims
Label ingredients in descending order by weight