Can I sell sunscreen on Amazon, and what do I need?
Yes, once Amazon approves it as an over-the-counter drug. Sunscreen has no page of its own; the same over-the-counter drug rules apply. Every product needs its own NDC (National Drug Code), a Drug Facts label, and, where the law requires it, child-resistant packaging. Selling under your own brand also means getting your own labeler code, the part of the NDC that names your company.
See the plan for your product →This page covers sunscreen and other topical over-the-counter drugs, such as hand sanitizer. Amazon has no separate page for sunscreen; it follows the same rules as any OTC drug. The free check in the plan confirms which rules apply to yours.
What does Amazon ask for before you list sunscreen or other OTC drugs?
- Oral OTC drugs need lab tests from an ISO 17025 lab (the global standard for testing labs). They need a cGMP certificate (proof from an audit that the factory follows FDA's rules). The NDC (National Drug Code) goes on the product and the package. You need $1M of insurance too. A tester Amazon approves checks the documents.1
- All drugs need Drug Facts images in the listing. They need child-resistant packaging where the law requires it.2
- Sunscreen and hand sanitizer: no page of their own; the drug listing rules apply.2
- FBA: if asked, a safety data sheet from the last 5 years. Perfume, nail polish, aerosols and other chemicals can be dangerous goods too.3
- Decide whether the product needs a Prop 65 warning. If it does, set the warning type and chemical names on the Compliance tab.4
Also on Amazon for this product (2)
- Set it on each child SKU, not the parent. Amazon applies this even with fewer than 10 employees.4
- Don't send Amazon labels or signs.4
What does the law ask for, whatever the marketplace?
- Selling under your own brand? Get your own labeler code, the part of the NDC (National Drug Code) that names your company. The maker lists the drug under it.1
- A unique NDC (National Drug Code) on each product.2
- A Drug Facts panel, and a US address or phone for reports of bad reactions (adverse events).3
- If your name is on the label, keep adverse-event records 6 years.4
- FDA is moving the NDC to a longer, uniform 12-digit format, but not until 7 Mar 2033. Today's 10- or 11-digit codes still work until then.2
More the law asks for this product (3)
- California requires a clear warning before anyone is exposed to a chemical on its list.5
- Businesses with fewer than 10 employees are outside the law.6
- This plan doesn't yet say how or where to warn: on the label, in a notice to stores, or online. That waits until the official rules are read.
Sources (6) · read 27 Sep 2026
- 121 CFR 207.9 and 207.41, registration and listing. eCFR text as of 1 Sep 2026
- 221 CFR 207.33, the NDC (with the 12-digit format read, effective 2033). eCFR text as of 1 Sep 2026; the 91 FR 10770 amendment read
- 321 CFR 201.66 and 21 U.S.C. 352(x). eCFR text as of 1 Sep 2026
- 421 U.S.C. 379aa, adverse-event records. US Code, prelim edition
- 5Cal. Health & Safety Code 25249.6. California code
- 6Cal. Health & Safety Code 25249.11(b). California code
What does that look like for one product?
Say you package a mineral sunscreen under your own brand to sell on Amazon. The product needs the maker's NDC on it, plus your own labeler code since your name is on the label. The listing needs Drug Facts images, and the packaging is child-resistant where the law requires it.
What's the next step?
The plan lists every step for your product in order, with a source for each line. It opens with Amazon and the product type already picked, and you can change either. It's free, with no signup.
See the plan for your product →Not sure which FDA steps apply? The free certificate check shows them for your product, with the rule cited for each. Check which certificate you need — free →
Related
Checked against Amazon's and the government's own pages on 27 Sep 2026.