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Category 4 of 25 · Hawaii

Body Care

Soap, Lotion, Lip Balm & Scrubs

General Consumer Product
None req'd
License
FDA / DCCA
Agency
4.5%
GET
No drug claims
Key rule

What's Covered / What Needs More

✓ What's Covered

  • Cold-process and melt-and-pour soap, lotions, body butters, lip balm, and sugar/salt scrubs
  • Selling direct at markets, online, and wholesale to shops with a GET license
  • True 'soap' (as defined by FDA, made mainly of fats/oils + alkali, cleaning-only claims) is exempt from FDA cosmetic registration
  • Cosmetic-labeled products (lotion, balm) following FDA's Fair Packaging and Labeling Act ingredient/net-weight rules

✕ Needs More

  • No HDOH food permit applies — but claiming a product 'treats acne,' 'heals eczema,' or similar makes it an unapproved drug under federal law
  • No Hawaii-specific cosmetic manufacturing license exists, but MoCRA (federal) facility registration applies once you exceed the 'small business' revenue exemption
  • Bar soap that also claims to 'moisturize' or is marketed as a cosmetic loses its simple-soap exemption and must meet full cosmetic labeling rules
  • Products with SPF or antimicrobial claims are OTC drugs requiring FDA drug facility registration

How to Get Compliant

A

Classify: soap vs. cosmetic

True lye-based cleansing soap has the lightest federal burden; lotions/balms/scrubs are 'cosmetics' needing full FDA ingredient-declaration labeling.

B

Register your business

Get a GET license from the Dept. of Taxation; register under MoCRA with FDA if your gross revenue exceeds the small-business threshold (adjusted annually).

C

Label completely

List all ingredients in descending order by INCI name, net weight, business name/address, and avoid any therapeutic or drug-type claim on packaging or in marketing.

Quick Reference

Sales ChannelRequirementNotes
Farmers market / in-personGET licenseNo state cosmetic permit
Online statewide or interstateGET license, FDA cosmetic labelingMoCRA facility registration if above revenue threshold
Wholesale to a boutique/spaGET license (wholesale rate)Retailer may request ingredient safety documentation
Any SPF, antimicrobial, or 'treats X' claimFDA OTC drug registrationReclassifies product out of cosmetics entirely

Frequently Asked Questions

Do I need a Hawaii license to sell homemade soap?
No state manufacturing license is required, but you do need a GET license, and true soap has a lighter federal labeling burden than lotions or balms.
Can I say my lotion 'cures eczema'?
No — that is a drug claim and requires FDA drug approval; keep claims cosmetic ('moisturizes,' 'soothes dry skin').
What is MoCRA and does it apply to me?
The federal Modernization of Cosmetics Regulation Act (2022) requires facility registration and product listing for most cosmetic makers, with an exemption for small businesses under a revenue threshold — check current FDA guidance for the exact figure.
Can I sell bath products across state lines?
Yes, cosmetics generally may ship interstate under FDA rules; there's no Hawaii-specific restriction beyond standard labeling.

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