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FDAUnited StatesLip balm

Does lip balm need FDA registration?

Updated

Short answer

Usually yes under MoCRA, unless you qualify as a small business. FDA does not approve it.

A plain lip balm is a cosmetic. Cosmetics do not need FDA approval, but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the facility that manufactures or processes it to register with FDA and the responsible person, the brand on the label, to list each product with its ingredients. FDA began enforcing registration and listing on July 1, 2024. A lip balm with SPF or claims to treat or protect chapped lips is an OTC drug, which follows drug rules instead.

What changes the answer

  • Small business exemption. Under section 612 of the FD&C Act, a business with average gross annual U.S. cosmetic sales under $1,000,000 over the prior three years, adjusted for inflation, is exempt from registration, listing and the coming GMP rules, unless it makes products that contact the eye's mucous membrane, are injected, are for internal use, or alter appearance for more than 24 hours. A standard lip balm is not in those categories.
  • Foreign facilities. A foreign facility that makes cosmetics for the U.S. registers like a domestic one and names a U.S. agent in its registration.
  • Drug claims. SPF, sunscreen claims, cold sore claims or skin protectant claims for chapped lips make the product a drug, or a cosmetic and a drug, subject to the OTC monograph and drug establishment registration and listing.
  • Exemption limits. Small businesses are still subject to adverse event reporting, safety substantiation and labeling rules.

What to do

  1. Confirm the product is a cosmetic only: no SPF, no treatment or prevention claims on the label, listing or ads.
  2. Make sure the manufacturing facility is registered, and list the product through FDA's Cosmetics Direct portal with its ingredients. Update the listing each year.
  3. Label the product under 21 CFR part 701: identity, net quantity, ingredients in descending order of predominance under 701.3, and the name and place of business under 701.12.
  4. Add the domestic address, domestic phone number or electronic contact, such as a website, where the responsible person can receive adverse event reports, as MoCRA section 609 requires.
  5. Keep records that substantiate the product's safety, and report serious adverse events to FDA within 15 business days.
HTS line for lip balm
  • 3304.10.00.00

    3304: Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations

    Lip make-up preparations

    Lip make-up preparations. CBP has classified many lip balms here; tinted and medicated products can differ.

    General rate
    Free

Next steps

Frequently asked questions

Is there an FDA approval number for lip balm?
No. FDA does not approve cosmetics before sale. Registration and listing numbers do not mean FDA approval, and labels must not suggest otherwise.
I make lip balm at home and sell on Etsy. Do I register?
If your U.S. cosmetic sales average under $1,000,000 a year over three years, you are likely exempt from registration and listing. You still must follow labeling, adverse event reporting and safety substantiation rules.
Does a lip balm with SPF 15 need registration?
Yes, but as a drug: SPF products follow the OTC sunscreen monograph, drug labeling with a Drug Facts panel, and drug establishment registration and product listing.

Sources

  1. Modernization of Cosmetics Regulation Act of 2022 (MoCRA), U.S. Food and Drug Administration
  2. Registration and Listing of Cosmetic Product Facilities and Products, U.S. Food and Drug Administration
  3. FDA issues compliance policy for cosmetic product facility registration and product listing, U.S. Food and Drug Administration
  4. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), U.S. Food and Drug Administration
  5. 21 CFR 701.3, Designation of ingredients, eCFR, National Archives

This is general information drawn from the official sources linked above. It is not legal advice. Rules change and often turn on the facts of your product, so confirm your test plan with an accredited lab and your obligations with qualified counsel before you import or sell.