Key Facts · 2026-09-27
- In the EU, sunscreen is a cosmetic product under Regulation (EC) No 1223/2009, and Annex VI caps each permitted UV filter at a maximum concentration.
- EU SPF is tested to ISO 24444 in vivo, or to ISO 24442 in vitro with a UVA correction factor, and the UVA protection level must be at least one third of the labeled SPF.
- In the United States, sunscreen is an over-the-counter drug under 21 CFR 352, so broad spectrum claims are drug claims governed by the FDA, not cosmetic claims.
- Australia and New Zealand regulate sunscreen as therapeutic goods, requiring TGA entry on the ARTG and AUST L consumer medicine information, tested to AS/NZS 2604.
- On 2026-03-26 the TGA opened a consultation on SPF labeling reform covering in vitro ISO 23675 testing, three possible SPF label options and accreditation of testing laboratories.
- A CHOICE survey in Australia tested 20 sunscreens and found 16 failed to meet the standard, which is why testing decides whether a product is sellable there.
- For OEM manufacturing, SPF testing cost pushes typical sunscreen MOQ to 3,000 to 5,000 units per SKU, far above ordinary skincare.
Why SPF 50 does not mean the same thing everywhere
A sunscreen that is legal and honest on a German shelf can be a misbranded drug in the United States and an unlisted therapeutic good in Australia. The SPF number printed on the front of the bottle looks the same. The rule behind it is not.
The split starts before anyone measures performance: it starts with the legal category. Cosmetic, drug, therapeutic goods. Three categories, three test protocols, three permitted label sentences, and three different sets of documents an inspector can ask for. Choosing the wrong category at the drawing board costs far more than choosing the wrong adjective at the printer.
The EU: a cosmetic claim with a filter ceiling attached
In the European Union, sunscreen is a cosmetic product under Regulation (EC) No 1223/2009. What that means in practice is that your formula is bounded by a list before marketing has any say: Annex VI of that regulation sets the maximum concentration for every permitted UV filter.
Performance is then measured under ISO 24444 in vivo, or through the ISO 24442 in vitro route with a UVA correction factor. The UVA protection level has to reach at least one third of the labeled SPF, which is why an EU label carries a UVA logo rather than a PA rating, and why two laboratories can land a few SPF points apart on the same formula.
- Annex VI to Regulation (EC) No 1223/2009 defines the permitted UV filter list and the maximum concentration for each filter in EU sunscreen.
- ISO 24444 in vivo is the reference SPF method; ISO 24442 in vitro is accepted where a UVA correction factor is applied.
- The UVA protection level must be at least the labeled SPF divided by three.
- Wording such as SPF 50+ is permitted in the EU, but the surrounding claims are still constrained by the same regulation.
The United States: sunscreen is an approved over-the-counter drug
In the United States, sunscreen is regulated as an over-the-counter drug under 21 CFR 352 rather than as a cosmetic. That single reclassification changes who is allowed to make the claim and what paperwork has to survive an FDA inspection.
A product may only be called broad spectrum when it meets the FDA criteria for critical wavelength and UVA protection factor, and the monograph limits the labeling most products may use, with SPF 50 remaining the practical ceiling for routine claims. This is why American shelves converged on SPF 30 and SPF 50 labeling while European shelves still show SPF 50+.
- Confirm the formula falls within the OTC sunscreen drug monograph in 21 CFR 352.
- Validate SPF using FDA-recognized in vitro and in vivo test methods.
- Establish broad spectrum status against the FDA critical wavelength and UVA protection factor criteria.
- Apply drug labeling requirements: statement of identity, indications, warnings, directions and the Responsible Person address.
- Retain master formula and batch records so the listing can be defended during an inspection.
Australia and New Zealand: therapeutic goods, ARTG listing and AUST L
Australia and New Zealand take the third route and treat sunscreen as a therapeutic good. The Therapeutic Goods Administration requires the product to be entered on the Australian Register of Therapeutic Goods, and the sponsor must supply consumer medicine information formatted as AUST L.
Performance is tested against AS/NZS 2604, the most literal of the three on paper, and also the one where the market has moved furthest: on 2026-03-26 the TGA opened a consultation on SPF labeling reform, covering in vitro testing to ISO 23675, three possible SPF label options, and accreditation of the laboratories allowed to run the tests.
A sunscreen that passes in Europe can still fail in Australia, because the Australian standard is applied to the finished product rather than to the claim printed on the box.
What this means if you manufacture in China
Chinese contract manufacturing can supply all three markets, but only if the factory brief written in the first week already assumed three regulatory endings. Retrofitting a formula usually means a new stability run, a new filter set and a new test invoice.
SPF testing is charged per SKU and per market, and it is the main reason sunscreen MOQ sits at 3,000 to 5,000 units per SKU instead of the 500 to 1,000 units common for a cleanser or a toner. Budget it into your first purchase order rather than discovering it in the second.
- Lock the SPF test per market before you freeze the formula, because the three regions rarely share one filter set.
- Ask the factory for the facility registration number and batch traceability evidence in writing, not on a business card.
- Expect the widest gap in sunscreen and sheet masks, where testing and tooling both scale with unit count.
Frequently Asked Questions
Brief your sunscreen factory against the target market
Send us the three markets you are launching in. We will tell you which filter set, which test protocol and which MOQ applies before you commit to a formula.
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