Pick up a sunscreen in Paris and another in Miami and you are holding products made under two different rulebooks. In the European Union a sunscreen is a cosmetic. In the United States it is an over-the-counter drug. That single difference decides which UV filters a formula is allowed to use, how a new filter gets approved, and what a brand may say on the label.
Europe: sunscreen is a cosmetic
In the EU, sunscreens fall under the Cosmetics Regulation, (EC) No 1223/2009. The UV filters a product may contain are listed in Annex VI of that regulation, each with its own maximum concentration, and the list is updated as Europe’s scientific committee reviews new safety data.
Europe also asks for more than a sun protection factor. Since 2006 the European Commission has recommended that every sunscreen protect against UVA as well as UVB, with UVA protection of at least one third of the labelled SPF and a critical wavelength of at least 370 nm. It also recommends that no sunscreen claim to give 100% protection, using words such as “sunblock” or “total protection”.
The United States: sunscreen is a drug
In the US, sunscreen active ingredients are governed by the FDA’s over-the-counter monograph for sunscreens. The monograph that took effect in 2020 lists 16 active ingredients. Of those, the FDA has proposed that only two, zinc oxide and titanium dioxide, are generally recognised as safe and effective. It has proposed that two others, PABA and trolamine salicylate, are not, and asked for more data on the remaining twelve.
Adding a new filter to that list has been slow. In June 2026 the FDA issued a final order adding bemotrizinol, at up to 6%, the first new active ingredient added to the US sunscreen monograph since the late 1990s. Bemotrizinol has been used in Europe for many years.
The filters Europe has and the US does not
Several of the newer filters on Europe’s list are still not on the US monograph, among them bisoctrizole, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, diethylhexyl butamido triazone and drometrizole trisiloxane. They were developed for strong, stable UVA and UVB protection and a lighter feel on the skin, and they are part of why European sunscreens are often described as more elegant to wear.
Why SOLA makes two editions
Because the rules differ, SOLA makes a separate formula for each market rather than one product for both.
The European Edition. The product is an anhydrous oleogel SPF 50 — water-free, no emulsion, organic UV filters. It is made to the EU Cosmetics Regulation and launches across the European Union in late spring 2027. Read about the European Edition.
The US Edition. A mineral SPF 50 made to the FDA’s rules, using zinc oxide and titanium dioxide, the two filters the FDA has proposed as safe and effective. It is in final testing and launches in 2027. Read about the US Edition.
Sources
- Commission Recommendation 2006/647/EC on the efficacy of sunscreen products
- FDA: Questions and answers on the deemed final order and proposed order for OTC sunscreen
- Federal Register, 10 June 2026: adding bemotrizinol to OTC Monograph M020
- CIRS: US FDA approves bemotrizinol as a new sunscreen active ingredient
Be first.
SOLA launches across the European Union in late spring 2027, and in the United States in 2027. The first two hundred people on the list become founding members.
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