UV Filters Compared: Which Sunscreen Ingredients Are Approved Where?

Sunscreens are simultaneously the most regulated and the most globally fragmented category in cosmetics. Whether an ingredient can legally be called a UV filter — and at what concentration — depends entirely on the country where the product is sold. The result is that a sunscreen available in South Korea, Japan, Australia, or the EU may contain UV-absorbing compounds not approved in the US, often offering broader-spectrum protection at lower whitish-cast concentrations. Understanding why requires a look at how different regulatory bodies classify sunscreens and evaluate new filter technologies.

How Different Regulators Classify Sunscreens

The first critical difference is product classification. In the United States, sunscreens are regulated as over-the-counter (OTC) drugs by the FDA under a monograph system. This means every active UV-filtering ingredient must either be listed on the approved OTC monograph or go through a full New Drug Application (NDA) or Time and Extent Application (TEA) process. No new UV filter has been added to the US OTC sunscreen monograph since the 1970s, despite numerous TEA submissions from European manufacturers.

In the European Union, sunscreens are regulated as cosmetics under Regulation (EC) No 1223/2009. New UV filters are evaluated by the Scientific Committee on Consumer Safety (SCCS), and if approved, are added to Annex VI. This process, while rigorous, operates within a cosmetics framework rather than a drug framework — meaning the burden of proof follows the cosmetics standard rather than a pharmaceutical-level drug approval process.

Australia (TGA), Japan (MHLW/quasi-drug system), and South Korea (MFDS) each maintain their own UV filter positive lists, generally approving a broader range than the US but with their own specific concentration limits and product-type restrictions.

FDA Category I: The Only Two Filters Recognized as GRASE

Zinc Oxide

Zinc oxide is the broadest-spectrum mineral UV filter, providing protection across UVB (290–320 nm) and deep into UVA I (340–400 nm). It is the only UV filter with true broad-spectrum coverage as a single ingredient.

The FDA classifies zinc oxide as Category I (GRASE) at concentrations of 2–25%. It is permitted in the EU under Annex VI at up to 25% in face products (non-nano form, or nano form if specifically authorized with [nano] labeling). Japan's MHLW permits zinc oxide in quasi-drug sunscreens at up to 25%. Australia's TGA approves it at up to 25%.

The EU's nano-specific regulations are worth noting: nano-particle zinc oxide (particle size <100 nm) must be specifically authorized and labeled as "[nano]" in the INCI list. The SCCS reviewed nano ZnO in 2012 and 2013 and concluded it was safe when applied to healthy intact skin, but data on damaged or sunburned skin were deemed insufficient at the time.

Titanium Dioxide

Titanium dioxide is a mineral UV filter providing primarily UVB and short-wave UVA II protection (290–360 nm), with limited UVA I coverage compared to zinc oxide. The FDA classifies it as Category I (GRASE) at 2–25%.

Similar to zinc oxide, the EU permits titanium dioxide in cosmetics including sunscreens at up to 25%, with nano-form requiring specific authorization. The SCCS issued opinions on nano titanium dioxide in 2013 and 2016, concluding that nano TiO₂ used in sunscreens at up to 25% does not pose a risk to human health from dermal absorption — though inhalation risks from spray products led to separate EU guidance.

A notable EU regulatory development: in 2021, the European Chemicals Agency (ECHA) classified titanium dioxide as a Category 2 suspected carcinogen by inhalation under the CLP Regulation. This classification applies to the bulk chemical, not specifically to sunscreen products, but it has triggered labeling requirements on TiO₂-containing spray products sold in EU member states — not a ban on its use in sunscreens, but a precautionary labeling change.

FDA Category III: Active Filters Requiring More Data

Following FDA proposed rules in 2019 and 2021, 12 UV filter ingredients were placed in Category III (insufficient data to determine GRASE status). The FDA requested additional data including absorption, distribution, metabolism, excretion (ADME) studies and potential endocrine effects. A critical trigger was the Matta et al. 2019 and 2020 JAMA studies, which demonstrated that several chemical UV filters are systemically absorbed at levels exceeding the FDA's 0.5 ng/mL threshold above which additional nonclinical toxicology data are required. Systemic absorption above the threshold does not itself constitute a safety finding — it simply triggers additional data requirements under FDA's standard framework.

UV Filter (INCI)	FDA Status (2025)	EU Annex VI	Max Conc. (EU)
Zinc Oxide	Category I (GRASE)	Permitted	25%
Titanium Dioxide	Category I (GRASE)	Permitted	25%
Avobenzone (Butyl Methoxydibenzoylmethane)	Category III	Permitted	5%
Oxybenzone (Benzophenone-3)	Category III	Permitted (restrictions)	6% (leave-on face); labeling required
Octocrylene	Category III	Permitted	10%
Octinoxate (Ethylhexyl Methoxycinnamate)	Category III	Permitted	10%
Homosalate	Category III	Permitted (lowered limit)	7.34% (reduced from 10% in 2022 SCCS opinion)
Octisalate (Ethylhexyl Salicylate)	Category III	Permitted	5%

Oxybenzone (Benzophenone-3): Environmental Legislation

Oxybenzone drew significant public attention following research suggesting potential effects on coral reef ecosystems. The state of Hawaii passed Act 104 in 2018, becoming the first US jurisdiction to ban sunscreens containing oxybenzone (and octinoxate) from sale, effective January 1, 2021. The Pacific island nation of Palau enacted similar restrictions in 2018. Key West, Florida also passed a ban (though it was partially preempted by state legislation).

The scientific consensus on oxybenzone's coral reef impact remains debated. The US National Academies of Sciences, Engineering, and Medicine published a comprehensive review in 2022 noting that while laboratory studies showed effects on coral at high concentrations, field-level evidence of sunscreen-driven coral bleaching was limited and confounded by other environmental stressors including ocean temperature rise.

EU-Approved Filters Not Available in the US (As of 2025)

Bemotrizinol (Tinosorb S)

Bemotrizinol (marketed as Tinosorb S; INCI: Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine) is one of the most technologically advanced UV filters available. It is a broad-spectrum filter covering both UVB (peak ~310 nm) and UVA (peak ~340 nm) with high molar extinction coefficients. It is photostable (unlike avobenzone, which degrades under UV exposure without stabilizers) and has lipophilic character making it compatible with oil phases.

See bis-ethylhexyloxyphenol methoxyphenyl triazine in our ingredient database.

Bemotrizinol is approved in the EU (Annex VI, up to 10%), Australia (TGA), Japan, South Korea, and Canada. It is not approved by the FDA. Ciba Specialty Chemicals (now BASF) submitted a Time and Extent Application (TEA) to the FDA in 2003. As of 2025, the application has not been approved; the FDA has not completed its review. This regulatory delay — two decades without resolution — is a frequent point of criticism of the FDA's OTC monograph system for sunscreens.

Bisoctrizole (Tinosorb M)

Bisoctrizole (INCI: Methylene Bis-Benzotriazolyl Tetramethylbutylphenol) is a hybrid organic-inorganic filter that works through both UV absorption and UV scattering. It provides protection from UVB through UVA I (290–400 nm), is photostable, and has extremely low systemic absorption due to its high molecular weight (~659 g/mol).

Bisoctrizole is approved in the EU (Annex VI, up to 10%), Australia, Japan, and South Korea. Like bemotrizinol, it has a pending FDA application that has not been resolved as of 2025.

Diethylamino Hydroxybenzoyl Hexyl Benzoate (Uvinul A Plus)

Diethylamino hydroxybenzoyl hexyl benzoate (DHHB, marketed as Uvinul A Plus) is a high-efficiency UVA filter with a peak absorption around 354 nm, making it excellent for deep UVA I coverage. It is photostable and has low systemic absorption. Approved in the EU (up to 10%) and Australia, it is not on the FDA-approved list for the US.

Japan's UV Filter Regulations

Japan regulates sunscreens as quasi-drugs (医薬部外品) under the MHLW's positive ingredient list. Key characteristics of Japan's system:

• Only ingredients on the MHLW-approved positive list can be used as UV filters in quasi-drug sunscreens.
• Japan does not use the SPF+PA system alone — it uses PA+ through PA++++ ratings for UVA protection (based on Persistent Pigment Darkening methodology).
• Japan permits 4-methylbenzylidene camphor, which is EU-restricted (pending SCCS review) and not FDA-approved. Maximum permitted concentration is 4% in Japan.
• Maximum concentrations in Japan are often lower than EU limits: e.g., oxybenzone is permitted at up to 5% in Japan vs. 6% in the EU.
• Japan's list includes several filters not found in EU Annex VI or FDA-approved lists, and vice versa, reflecting decades of independent regulatory development.

South Korea (MFDS) and Canada (Health Canada)

South Korea's Ministry of Food and Drug Safety (MFDS) regulates sunscreens as functional cosmetics, maintaining a positive list that largely mirrors EU approvals with some additions and different concentration limits. South Korea has approved over 30 UV filter substances.

Canada (Health Canada) classifies sunscreens as natural health products (NHPs) and maintains its own approved active ingredient list. Canada has approved several UV filters not on the FDA list, including bemotrizinol and bisoctrizole, making it another market where broader-spectrum single-ingredient protection is commercially available.

Why Does This Matter Practically?

The practical consequence of the US's narrow approved UV filter list is primarily a formulation challenge, not necessarily a safety gap. US formulators wanting to achieve high broad-spectrum SPF must typically use combinations of the approved chemical filters (avobenzone, oxybenzone, octocrylene, etc.) or rely on high concentrations of zinc oxide and/or titanium dioxide — which can leave more visible white cast, particularly in higher-SPF mineral formulations.

Photostability is also a concern: avobenzone, the primary UVA filter in the US approved-filter toolkit, is inherently photounstable, degrading upon UV exposure. US formulators address this by pairing avobenzone with octocrylene or other photostabilizers, adding formulation complexity. EU formulators can instead use the inherently photostable bemotrizinol or bisoctrizole as stand-alone broad-spectrum filters.

Consumers who import sunscreens from Japan, South Korea, Australia, or Europe for personal use should be aware that these products comply with their country of origin's regulations, not FDA rules. This is relevant for anyone reselling or distributing such products in the US.

Use our Ingredient Analyzer to check the regulatory status of any UV filter or sunscreen ingredient across multiple jurisdictions.