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Mixed / Verify Before Selling

Body Care

Lotions, balms, scrubs, and cosmetic-grade soap for direct sale in Iowa

None
Iowa-specific license
MoCRA (2022)
Federal framework
GMP/registration only
Small business break
Safety substantiation
Never exempt from
What's covered vs. what needs a different path

Covered here

  • Lotions, balms, body butters, scrubs, and lip care sold with cosmetic claims (moisturizes, softens)
  • True lye soap with no cosmetic or drug claims (regulated separately as a consumer product)
  • Bath bombs, bath salts, and non-drug skincare
  • Small operations under $1M in average annual cosmetic sales (partial MoCRA relief, not a full exemption)

Needs a different path

  • Any product claiming to treat acne, eczema, wrinkles, or other medical conditions (becomes an FDA drug)
  • Sunscreen or anything with an SPF claim (regulated as an OTC drug, not a cosmetic)
  • Products made in a facility that also triggers separate state food or feed licensing
  • Skipping safety substantiation — this applies to every size of business, no exemption
How to get compliant
A

Register your facility and list your products

Under the Modernization of Cosmetics Regulation Act, anyone manufacturing or processing cosmetics for U.S. consumers — including farmers market and online sellers — registers their facility with FDA and lists each product, renewing every two years.

B

Document safety substantiation

Keep a written safety file per formula: ingredient review, exposure assessment, and confirmation the product isn't adulterated. This requirement applies to every business size — there is no small-business exemption from it.

C

Use the small-business relief correctly

Businesses averaging under $1,000,000 in annual U.S. cosmetic sales over three years can skip formal Good Manufacturing Practice audits and some registration/listing timing, but only for lower-risk products — talc, injectables, and a few other categories are carved back out.

Quick reference
ItemRuleRegulator
Facility registrationRegister with FDA; renew every 2 yearsFDA (MoCRA)
Product listingList each product and its ingredients with FDAFDA (MoCRA)
Safety substantiationWritten safety file per formula; no size exemptionFDA (MoCRA §608)
Adverse event reportingReport serious adverse events to FDA within 15 business daysFDA (MoCRA)
True soap (lye-saponified, no cosmetic claim)Regulated as a consumer product, not a cosmeticCPSC
Frequently asked
Is my handmade soap exempt from all of this?

Only if it's true soap — made by saponifying fats with lye and sold purely as soap, with no lotion-like or skin-treatment claims. Add a moisturizing or anti-aging claim and it becomes a cosmetic under MoCRA.

Does Iowa require its own cosmetics license on top of MoCRA?

No separate Iowa state cosmetics license exists for handmade body care; MoCRA is the primary framework, though your city or county may require a general business license.

What does the small-business exemption actually skip?

It can relieve you from formal GMP recordkeeping and some registration/listing deadlines, not from safety substantiation or adverse event reporting — those apply to everyone.

Can I sell body care and food from the same home kitchen?

You can, but keep the operations and licensing separate in your paperwork — cosmetics fall under MoCRA/FDA while foods fall under Iowa's cottage food or food establishment rules, and a shared workspace needs to satisfy both sets of standards.

Printable checklist
  • FDA facility registration filed and renewal date tracked (every 2 years)
  • Every product listed with FDA, ingredients included
  • Written safety substantiation file kept per formula
  • Copy reviewed to remove disease/treatment claims (or route to OTC drug rules)
  • Confirmed whether 3-year average sales qualify for small-business relief
  • Process in place to report serious adverse events within 15 business days