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The FDA sunscreen framework has reached a major regulatory milestone in the United States. For the first time in more than two decades, the U.S. Food and Drug Administration has approved a new active ingredient for use in over-the-counter sunscreen products: Bemotrizinol, also known as BEMT and identified in cosmetic ingredient terminology (INCI) as Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine.
This FDA sunscreen update is significant because it introduces a modern broad-spectrum UV filter into the US market and highlights the long-standing regulatory differences between the United States and other major cosmetic markets, particularly the European Union and the United Kingdom.
What is Bemotrizinol?
Bemotrizinol is an organic UV filter used in sunscreen products to help protect the skin from ultraviolet radiation. It is valued in sun care formulation because it provides broad-spectrum protection, meaning that it contributes to protection against both UVA and UVB radiation.
This distinction is important because UVB radiation is mainly associated with sunburn, while UVA radiation penetrates more deeply into the skin and is linked to photoaging and long-term sun-related skin damage. A well-designed sunscreen product should provide balanced protection across both regions of the ultraviolet spectrum.
Bemotrizinol is also known for its photostability. In practical formulation terms, this means that it can maintain its protective function when exposed to sunlight more effectively than some older UV filters. Photostability is especially relevant for sunscreen products because UV filters are expected to perform under direct light exposure, often for prolonged periods.
From a formulation perspective, Bemotrizinol can support the development of high-performance sunscreen products with a more elegant sensory profile. Modern consumers expect sun care products to be effective, pleasant to apply, suitable for daily use and compatible with different skin tones and product formats. The availability of an additional UV filter gives formulators more flexibility to meet these expectations while maintaining compliance with applicable regulatory requirements.
Why is this FDA sunscreen approval so important?
The most remarkable aspect of this approval is the timing. Bemotrizinol is the first new active ingredient added to the US OTC sunscreen monograph since the late 1990s. In an industry where formulation science has advanced significantly over the past two decades, this is an important regulatory and commercial development.
For many years, sunscreen innovation in the United States has been constrained by the limited number of UV filters available under the US OTC sunscreen framework. By contrast, other regions, including the European Union and the United Kingdom, have allowed the use of a broader range of UV filters in cosmetic sunscreen products, subject to specific concentration limits and conditions of use.
The approval of Bemotrizinol helps reduce part of this regulatory gap. It gives US sunscreen manufacturers access to a UV filter that has already been used in many international markets and is well known within the global sun care industry. This may support the development of products with improved broad-spectrum performance, better UVA protection strategies and more consumer-friendly textures.
The decision is also relevant from a public health perspective. Sunscreen use is an important part of sun protection behavior, but consumer compliance is strongly influenced by product acceptability. If sunscreen feels heavy, greasy, whitening, sticky or unpleasant, consumers may be less likely to apply it properly or reapply it as needed. Regulatory access to more modern UV filter technologies can therefore support the development of sunscreen products that are both effective and more appealing to consumers
Bemotrizinol in the European Union and the United Kingdom
Bemotrizinol is not new to the European Union or the United Kingdom. In these markets, it is already listed as an approved UV filter under Annex VI of the Cosmetics Regulation.
Annex VI is the positive list of UV filters permitted for use in cosmetic products in the EU and in the UK. This means that only substances included in this annex may be used for the purpose of UV protection in cosmetic sunscreens, and they must be used according to the specific conditions established in the regulation, such as maximum concentration limits and any additional requirements.
In the EU and UK, Bemotrizinol is identified by its INCI name, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine. Its inclusion in Annex VI reflects the European and UK approach to sunscreen regulation: sunscreens are cosmetic products, but the UV filters used in them are subject to prior safety assessment and inclusion in a dedicated regulatory annex.
This allows the EU and UK to regulate sunscreen products within the cosmetic framework while still applying specific controls to UV filters. As a result, EU and UK sunscreen formulators have historically had access to a wider range of approved UV filters than their US counterparts, including several filters that are not yet available or have only recently become available in the United States.
The key regulatory difference: cosmetics in the EU and UK, OTC drugs in the US
One of the most important lessons from this FDA sunscreen milestone is the difference in how sunscreens are classified and regulated across jurisdictions.
In the EU and UK, sunscreens are regulated as cosmetic products. They must comply with the applicable Cosmetics Regulation, including requirements on safety assessment, Product Information File, Responsible Person, Good Manufacturing Practice, labelling, claims substantiation, notification and compliance with the annexes governing prohibited, restricted and permitted substances.
Although sunscreen claims relate to protection from UV radiation, the product remains a cosmetic product under EU and UK law when its intended function is to protect the skin from sun exposure and maintain it in good condition. The regulatory emphasis is placed on product safety, correct use of permitted UV filters, accurate labelling, substantiated claims and consumer protection.
In the United States, sunscreens are regulated differently. They are considered over-the-counter drugs because they are intended to help prevent sunburn and reduce risks associated with UV exposure when used as directed. As OTC drugs, sunscreen products must comply with the applicable FDA monograph requirements or otherwise obtain approval through a drug pathway.
This difference has major practical consequences. The approval process for new sunscreen active ingredients in the US is more complex, data-intensive and time-consuming than the process applicable to cosmetic UV filters in many other regions. This helps explain why Bemotrizinol could be widely used internationally for years while remaining unavailable in US OTC sunscreen products until now.
EU and UK sunscreen regulation vs US FDA sunscreen regulation
Regulatory aspect | EU and UK | United States |
Product classification | Cosmetic product | OTC drug |
Main regulatory framework | Cosmetics Regulation | FDA OTC sunscreen monograph |
UV filter control | Positive list in Annex VI | Permitted active ingredients under the OTC monograph |
Product file | PIF and CPSR required | OTC drug compliance documentation required |
Claims approach | Cosmetic claims must be substantiated | Claims must align with OTC drug indications and labelling |
Market access logic | Cosmetic compliance before placing on the market | Compliance with OTC monograph or drug approval pathway |
This distinction is essential for companies developing sunscreen products for multiple markets. A formula that is compliant in the EU or UK is not automatically compliant in the United States, even if the product type, brand positioning or intended consumer use appears similar.
What does inclusion in the OTC sunscreen monograph mean?
The OTC monograph system can be understood as a regulatory framework for certain categories of nonprescription drugs. For sunscreens, the monograph defines key conditions such as permitted active ingredients, concentration limits, dosage forms, labelling requirements, indications, warnings and directions for use.
By adding Bemotrizinol to the OTC sunscreen monograph, FDA has created a route for sunscreen products containing this UV filter to be legally marketed in the United States, provided they comply with the applicable conditions.
This does not mean that any product containing Bemotrizinol can automatically be placed on the US market without further regulatory assessment. Finished products must still comply with all relevant OTC drug requirements. For cosmetic and sun care companies, the approval of Bemotrizinol creates an opportunity, but not a shortcut. Compliance must still be assessed at finished product level.
What could this mean for sunscreen innovation?
The addition of Bemotrizinol may have a meaningful impact on sunscreen development in the US market.
Sunscreen development often requires balancing multiple factors, including SPF, UVA protection, photostability, skin feel, transparency, compatibility with other ingredients, water resistance, packaging, claims and consumer expectations. Access to an additional high-performance UV filter can make this balance more flexible.
This approval may also encourage further regulatory activity around other UV filters. The US has historically lagged behind other markets in sunscreen filter availability, and the successful addition of Bemotrizinol may create momentum for further modernization of the sunscreen monograph system.
However, expectations should remain realistic. Each ingredient requires appropriate data, regulatory review and compliance with the applicable legal framework. The approval of Bemotrizinol is an important step, but it does not eliminate the need for careful product-specific regulatory assessment.
A bridge between global sunscreen markets
From a global regulatory perspective, Bemotrizinol’s approval is a step towards greater alignment between the US and international sunscreen markets.
For multinational brands, differences in UV filter approvals create major formulation challenges. Sunscreen developed for the EU or UK may not be directly transferable to the US because the active UV filters permitted in the EU and UK may not be permitted under the US OTC sunscreen monograph. This often forces companies to develop separate regional formulas, with different performance profiles and different ingredient systems.
The addition of Bemotrizinol does not eliminate these differences, but it reduces one important barrier. It may allow brands to develop sun care products with more harmonized UV filter strategies across regions, although full compliance must still be assessed separately for each market.
For consumers, the decision may eventually translate into greater product choice and improved access to modern sunscreen technologies. For regulators, it shows that innovation and safety evaluation can progress within the OTC monograph system when sufficient data and regulatory mechanisms are available.
Regulatory considerations for sunscreen companies
Companies planning to use Bemotrizinol in US sunscreen products should approach the approval carefully and strategically.
First, companies should confirm the exact regulatory conditions under the amended OTC sunscreen monograph. The approval of the ingredient does not remove the need to comply with all other monograph requirements.
Second, the finished product formula must be assessed. Sunscreen compliance is not determined by the presence of an approved UV filter alone. The final product must meet the applicable requirements for composition, dosage form, labelling, claims and intended use.
Third, companies should review market-specific claims. Claims that may be acceptable in the EU or UK cosmetic framework may not be appropriate in the US OTC drug context. In the United States, sunscreen claims must align with permitted OTC drug indications and labelling requirements.
For EU and UK products, companies must continue to comply with the applicable Cosmetics Regulations. This includes the use of UV filters only as permitted under Annex VI, preparation of a Product Information File, Cosmetic Product Safety Report, Responsible Person obligations, notification, compliant labelling and claims substantiation.
Even where the same UV filter is used in more than one region, the regulatory framework remains different.
How Cosmeservice supports brands with FDA sunscreen regulation
This FDA sunscreen update also illustrates a fundamental difference between two major regulatory systems: in the EU and UK, sunscreens are cosmetics; in the United States, they are OTC drugs. This classification difference has a direct impact on ingredient approval, product development, claims, labelling and time to market.
For the cosmetics and sun care industry, the approval of Bemotrizinol is an encouraging step. It may support more effective, elegant and globally aligned sunscreen formulations. At the same time, companies must remember that regulatory compliance remains market-specific and must be assessed at finished product level.
At Cosmeservice, we support cosmetic and sun care companies in assessing sunscreen compliance across different markets, including formula review, labelling, claims assessment and regulatory strategy for the EU, UK and US markets.
To understand how this FDA sunscreen update may affect your sun care products and how to assess compliance across the US, EU and UK markets, complete our contact form or contact us at info@cosmeservice.com.
FAQs
What is the latest FDA sunscreen update?
The latest FDA sunscreen update is the approval of Bemotrizinol as a new active ingredient for use in over-the-counter sunscreen products in the United States. This is an important milestone because it is the first new sunscreen active ingredient added to the US OTC sunscreen monograph since the late 1990s.
What is Bemotrizinol?
Bemotrizinol is an organic UV filter used in sunscreen products. It is also known as BEMT and its INCI name is Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine. It helps provide broad-spectrum protection against UVA and UVB radiation.
Is Bemotrizinol approved in the United States?
Yes. FDA has approved Bemotrizinol as a permitted active ingredient in OTC sunscreen products, subject to the applicable monograph conditions. Finished products containing Bemotrizinol must still comply with all relevant US OTC sunscreen requirements.
Does this mean sunscreens with Bemotrizinol can be sold immediately in the US?
Not automatically. The ingredient approval creates a regulatory pathway, but finished products must still comply with the OTC sunscreen monograph, including requirements related to concentration, dosage form, permitted combinations, labelling, indications, warnings and directions for use.
Are sunscreens regulated as cosmetics in the United States?
No. In the United States, sunscreens are regulated as over-the-counter drugs because they are intended to help prevent sunburn and reduce risks associated with UV exposure when used as directed. This is different from the EU and UK, where sunscreens are regulated as cosmetic products.
Why is the approval of Bemotrizinol important for sunscreen innovation?
The approval gives US formulators access to an additional modern UV filter that can support broad-spectrum protection, photostability and more flexible formulation development. It may help brands create sunscreen products with improved performance and a more pleasant sensory profile.
