Two sunscreens can carry the same UV filter at the same percentage and be perfectly legal in one country and unsellable in the next. Nothing about the molecule changed. What changed is which of two questions the market asks: is this ingredient classified as a drug or as a cosmetic, and is it on that market's own list.
This is the compliance half of the sun care story. Our earlier guide worked through how organic filters absorb and how to combine them (Organic UV Filters, Decoded). This one is about borders: which filter is permitted where, at what ceiling, and what actually moved in the last two years.
Five markets, four systems
The classification, not the chemistry, decides everything. A filter can be a well-characterised cosmetic ingredient in one framework and a substance with "insufficient data" in another, and a finished product can need nothing more than a notification or a full per-product registration.
| Market | Sunscreen is legally | Regulator | Type of list | Permitted filters | Route to market |
|---|---|---|---|---|---|
| United States | an OTC drug | FDA | closed monograph (M020) | 16 monograph actives, plus bemotrizinol from 2026 | meet the monograph; no pre-approval |
| European Union | a cosmetic | national authorities, notified through CPNP | positive list (Annex VI, Regulation (EC) 1223/2009) | 30 | CPNP notification with a PIF and safety report; no pre-approval |
| China | a special cosmetic | NMPA | positive list (Table 5 of the Safety and Technical Standards) | 27 | per-product special cosmetic registration |
| Japan | a quasi-drug | MHLW and PMDA | its own positive list | roughly 30 | per-product quasi-drug approval |
| Australia | a therapeutic good | TGA | its own approved filter list | about 30 | ARTG listing (AUST L) for primary sunscreens |
Read the first row carefully. In the United States a sunscreen is a drug, which means a filter cannot simply be added to a formula: it has to be on the monograph, or the product needs a New Drug Application. Everywhere else a filter is a listed ingredient, but it is the destination market's list that counts. There is no mutual recognition in sun care anywhere, and a formula that complies in Seoul, Shanghai or Paris is not thereby compliant in Sydney, Los Angeles or Tokyo.
The US list: closed, short, and finally one filter longer
In February 2019 the FDA proposed a rule that sorted the sixteen actives then on the US monograph into three categories. Zinc oxide and titanium dioxide were classified as generally recognised as safe and effective (GRASE). Para-aminobenzoic acid and trolamine salicylate were classified as not GRASE. The remaining twelve - avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O and sulisobenzone - had, in the agency's words, insufficient data to support a positive GRASE determination at that time.
That proposal was never finalised, and for two decades the practical result was a frozen list: no new sunscreen active entered the US market between the 1990s and 2026. On 9 June 2026 the FDA issued final order OTC000039, amending OTC Monograph M020 to add bemotrizinol (CAS 187393-00-6) at concentrations up to 6 percent, for adults and children six months and older. It is the first new sunscreen active added to the US monograph in about twenty years, and the first to arrive through the administrative order route that the CARES Act created: the proposed order was published on 11 December 2025, so the amendment took roughly seven months from proposal to final order.
Two consequences matter commercially. First, US formulators finally have a photostable broad-spectrum triazine, which is the single biggest weakness of a filter set built on avobenzone plus octocrylene. Second, the administrative route is now proven, and it is the realistic path for the next filter rather than a two-decade wait.
Watch the ceiling. Bemotrizinol is capped at 6 percent in the United States against 10 percent in the EU and in China. The grade a buyer purchases is the same material; the use level allowed in the finished product is not.
Benzophenone-3: a concentration limit is not portable
Benzophenone-3 (CAS 131-57-7) is the cleanest illustration of the problem. In the EU its entry in Annex VI splits the maximum by product type, and the split is the substance of the rule:
| Product type | EU (Annex VI) | China, from 1 January 2028 | US monograph |
|---|---|---|---|
| Face, hand and lip products | 6% | 6% | 6% |
| Body products, including propellant and pump sprays | 2.2% | 2.2% | 6% |
| Other products | 0.5% | 0.5% | 6% |
Two details in the EU entry are routinely missed. First, a product-protection allowance of up to 0.5 percent, with the arithmetic written into the annex: where 0.5 percent is used to protect the formulation, the level used as a UV filter must not exceed 5.5 percent in the face, hand and lip category, or 1.7 percent in the body category. Second, the outer packaging must state "Contains Benzophenone-3" - a label requirement, waived only where the concentration is 0.5 percent or less and the substance is used purely for product protection.
China's 2025 amendment to its Safety and Technical Standards adopted the same structure: 6 percent for face, eye, lip and hand products, 2.2 percent for body products and 0.5 percent for other products, not permitted in products carrying an inhalation risk, with "contains benzophenone-3" on the label. The previous Chinese figure was a flat 10 percent, and the new conditions apply from 1 January 2028. So for a supplier, benzophenone-3 now has one chemistry and three different legal identities.
Then there is a third layer entirely, because in some markets the question is not the concentration but the sale.
Reef rules are local law, not a claim
"Reef safe" has no legal definition and is not harmonised in any market. What exists is a set of local prohibitions that bite at the point of sale:
- Hawaii, Act 104 (2018). From 1 January 2021 it is unlawful to sell, offer for sale or distribute in the state any sunscreen containing oxybenzone or octinoxate without a prescription. Facial cosmetics are carved out. Later attempts to extend the same treatment to avobenzone and octocrylene have not been enacted.
- Palau (2020). The broadest restriction anywhere, covering ten named filters and leaving mineral filters as the practical route to compliance.
- Other jurisdictions. Key West, the US Virgin Islands, and marine parks in Thailand and Mexico each keep their own list, and they do not match each other.
The practical rule for an exporter: keep reef-restricted filters out of the SKUs aimed at reef-tourism destinations, and write claims that describe the formulation rather than an undefined standard. A product free of oxybenzone and octinoxate is compliant in Hawaii and says nothing about Palau.
Homosalate: the first filter deliberately cut
| Market | Limit and scope today | Basis |
|---|---|---|
| EU | 7.34%, face products only, excluding propellant sprays | Commission Regulation (EU) 2022/2195, after the SCCS reassessment of endocrine activity. Non-compliant products could no longer be placed on the Union market from 1 January 2025 and no longer be made available from 1 July 2025. |
| China | 7.34%, face products including the neck, plus eye and lip products; not for products with inhalation risk, from 1 January 2028 | 2025 amendment to Table 5 of the Safety and Technical Standards. The previous figure was 10%. |
| US | 15% | 21 CFR 352 sunscreen monograph. |
Nothing about the raw material changed. What changed is that a homosalate-based body spray is no longer placeable in the EU, while the identical formula remains fully compliant in the United States. The lesson for a purchasing team is that "sunscreen grade" homosalate is a raw-material claim; it is not a statement about any finished product, and it certainly does not travel between territories.
Octocrylene: legal everywhere, under two live threats
Octocrylene (CAS 6197-30-4) is the filter that stabilises avobenzone, which is why removing it from a chemical sunscreen is so difficult. It is currently permitted at 9 percent in propellant sprays and 10 percent in other products in the EU, at 10 percent in the US monograph, and in China at 9 percent for aerosols and 10 percent for other products from 1 January 2028 - another case of the Chinese amendment following the EU structure.
Two things are moving underneath it:
- The benzophenone residue. The EU entry already requires benzophenone, as an impurity and degradation product of octocrylene, to be kept at trace level. Benzophenone itself (CAS 119-61-9) has meanwhile been removed from Annex VI and placed on the prohibited list as a CMR substance. A high-residue octocrylene grade is therefore no longer a purity preference but a compliance risk in the finished product. Put the benzophenone figure on the specification and on the certificate of analysis now.
- The REACH restriction proposal. ECHA has proposed limiting octocrylene in cosmetics to 0.001 percent on persistent, bioaccumulative and toxic grounds, which would be a de facto phase-out if adopted. It is a proposal under consultation, not law, but it is the most consequential open file in sun care. It is the reason to qualify substitutes in advance - bemotrizinol and the triazines generally are the natural first candidates - rather than to wait for the final text and then reformulate under a deadline.
Same filter, five rulebooks
| Filter | CAS | EU (Annex VI) | US monograph | China (Table 5) | Australia |
|---|---|---|---|---|---|
| Benzophenone-3 (Oxybenzone) | 131-57-7 | 6% face/hand/lip; 2.2% body; 0.5% other | 6% | 6% / 2.2% / 0.5% from 2028 | 10% |
| Benzophenone-4 (Sulisobenzone) | 4065-45-6 | 5% as acid | 10% | 5% as acid, combined with Benzophenone-5 | 10% |
| Homosalate | 118-56-9 | 7.34%, face only, no propellant spray | 15% | 7.34% face, from 2028 | 15% |
| Octinoxate | 5466-77-3 | 10% | 7.5% | 10% | 10% |
| Octocrylene | 6197-30-4 | 9% propellant spray; 10% other | 10% | 9% / 10% from 2028 | 10% |
| Avobenzone | 70356-09-1 | 5% | 3% | 5% | 5% |
| Drometrizole Trisiloxane | 155633-54-8 | 15% | not permitted | listed | permitted |
| Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) | 302776-68-7 | 10%, with a 10 ppm cap on di-n-hexyl phthalate from 2027 | not permitted | 10% | permitted |
| Disodium Terephthalidene Dicamphor Sulfonate | 90457-82-8 | 10% as acid | New Drug Application routes only | listed | permitted |
| Bemotrizinol | 187393-00-6 | 10% | 6%, added June 2026 | 10% | permitted |
Read the table as a warning rather than a reference. The gaps are what cost money: three filters that a European or Chinese formulator takes for granted cannot be used in a US OTC product at all, and several that the US caps low are permitted higher in Europe and Australia. Any specification that names a filter without naming the destination market is incomplete.
Butyloctyl salicylate: the filter that is not a filter
Butyloctyl salicylate (CAS 190085-41-7) needs its own section, because it is the ingredient most often mistaken for a UV filter. It is not one. It does not appear in Annex VI, it is not a US monograph active, and it is not on China's Table 5. It is an oil-soluble ester, structurally close to octisalate, that absorbs in the UVB region around 295 to 315 nanometres and is used at 2 to 10 percent, typically 5 percent or less in sun care, as a solvent, emollient and photostabiliser.
Its commercial value is real. At 5 percent it is generally worth no more than about two SPF units, which is below the threshold the FDA applies to a UV active, and it does three useful things in a formula: it raises the polarity of the oil phase enough to keep crystalline filters such as bemotrizinol and ethylhexyl triazone in solution, it quenches the excited triplet state of avobenzone, and it wets mineral pigments so that zinc oxide spreads without the white cast. That is why it appears in mineral sunscreens - and why a "100 percent mineral" label should be read as describing the actives, not the whole formula.
For a buyer there are two consequences. Do not purchase it expecting it to replace a filter: it cannot carry a formula alone and it contributes no UVA protection. Do purchase it deliberately when the brief is solubility, pigment wetting or avobenzone stability, and specify it as the oil-phase tool it actually is.
What belongs on the purchase order
- Assay and isomer content. For bemotrizinol and the other triazines, the isomer distribution drives the extinction coefficient. Ask for it by name rather than accepting "purity".
- The residue on the restricted side. Benzophenone in octocrylene, and di-n-hexyl phthalate (DnHexP) in DHHB - the EU now caps DnHexP at 10 ppm as an unavoidable trace impurity, with the condition applying from 1 January 2027. Both figures belong on the specification.
- The right CAS for the right salt. Mexoryl SX is supplied as the acid and as the disodium salt, they carry different CAS numbers, and the EU entry lists them together as 10 percent "as acid". Confirm which one the price refers to.
- Heavy metals and residual solvents against the destination market's limit, because the same grade may end up in a cosmetic in one territory and an OTC drug in another.
- Photostability data as the percentage loss of the filter after a defined irradiation dose, not as a qualitative claim of being photostable.
Supply
All of the filters and functional esters discussed above are stocked and shipped from our Shanghai plant:
- Benzophenones: Benzophenone-3 (Oxybenzone) (CAS 131-57-7), Benzophenone-4 (4065-45-6)
- Salicylates: Homosalate (118-56-9), Butyloctyl Salicylate (190085-41-7)
- UVA-specific filters: Diethylamino Hydroxybenzoyl Hexyl Benzoate (302776-68-7), Disodium Terephthalidene Dicamphor Sulfonate (90457-82-8), Drometrizole Trisiloxane (155633-54-8)
Tell us the destination market and the SPF and UVA target, and we will confirm which filters in your formula survive that market's list, what the goods-in specification should carry, and which grade to quote.