Illinois · Direct-to-Consumer ComplianceGENERAL CONSUMER PRODUCT

Body Care

Soaps, lotions, balms, scrubs, deodorants and lip care

$1MMoCRA small-business line (3-yr avg)
15 daysSerious adverse events (business days)
Jul 1, 2028IL ingredient ban begins
6.25% + localGrooming products: general rate

1What’s covered & what needs more

Covered under this path

  • Lotions, balms, scrubs, bath products, hair care and lip balm — as FDA-regulated cosmetics
  • True soap made only from fats/oils + alkali and sold only as soap (CPSC-regulated; labeling rules are lighter)
  • Products with no drug or disease claims

Needs a different path

  • Sunscreen, acne, dandruff, antiperspirant or ‘medicated’ claims → OTC drug rules
  • Products marketed to treat eczema, wounds, etc. → drug rules
  • Eye-area, injectable, ingestible or long-lasting-appearance products → no small-business exemption
  • Anything edible (e.g., ‘lip products you can eat’) → food/cottage rules, not cosmetic

2Three steps to compliant sales

A

Classify: soap, cosmetic, or drug

True soap is a consumer product; lotions, balms and ‘moisturizing’ washes are cosmetics; treatment claims make a drug. Fix the claims before you print labels.

B

Build your MoCRA file

Even small makers must keep safety-substantiation records, report serious adverse events to FDA within 15 business days, and put a U.S. contact for adverse events on the label. Under $1M in average annual cosmetic sales you’re exempt from facility registration and product listing (GMP rules, once final, are also exempt for small businesses).

C

Label, tax, insure

Label with identity, net quantity, ingredients (descending order), and your name and place of business. Register with IDOR and charge the general sales-tax rate plus local tax. Illinois’ new cosmetic-ingredient ban starts July 1, 2028 — screen formulas now.

3Quick-reference table

ItemRuleRegulator
FDA registration / listingSmall businesses (< $1M avg. annual cosmetic sales, 3 yrs) exempt — except eye-area, injectable, ingestible and long-lasting-appearance products.FDA
Safety substantiationRequired for every cosmetic, every size of business.FDA
Adverse eventsReport serious events within 15 business days; keep records (3 yrs for small businesses); U.S. contact on label.FDA
Illinois ingredient banChemicals in Cosmetic Products Act (HB 3409, signed July 10, 2026): 24 intentionally added ingredients banned from July 1, 2028 — incl. certain phthalates, formaldehyde/releasers, mercury, some parabens, PFAS. Covers soaps and lotions.Illinois General Assembly
Sales taxPersonal grooming & hygiene products (soap, shampoo, lotions) are taxed at the general rate.IDOR

4Frequently asked

Is handmade soap regulated by FDA?

Only if it’s a cosmetic (claims beyond cleansing, or added moisturizers marketed as such). Plain soap sold as soap falls to CPSC labeling rules.

Do I need to test every batch?

MoCRA requires an adequate, documented basis that each product is safe. Talk to a cosmetic chemist or safety assessor about what fits your formulas.

Can I sell body care at a farmers market?

Yes as a general consumer product — the farmers-market rules for food don’t cover it, but check the market’s own vendor rules.

What happens in 2028?

Products with any of the 24 banned intentionally added ingredients can’t be made or sold in Illinois after July 1, 2028 (trace amounts that are technically unavoidable are excepted).

Printable checklist

  • Classify each SKU: soap / cosmetic / drug
  • Remove drug and disease claims
  • Safety-substantiation file for each formula
  • Adverse-event process + U.S. contact on labels
  • Ingredient list in descending order; net quantity; name & address
  • Screen ingredients against the 2028 Illinois list
  • Confirm < $1M 3-yr average (or register with FDA)
  • Register with IDOR; general-rate tax at checkout
Sales tax: General merchandise: 6.25% state rate plus local taxes. Register with IDOR through MyTax Illinois and look up the combined rate for each delivery address.