On June 17, 2026, the U.S. Food and Drug Administration (FDA) announced the approval of Bemotrizinol (BEMT) as a sunscreen active ingredient.
This marks a significant milestone for the US sunscreen industry, as it is the first new UV filter approved in more than 20 years.
While Bemotrizinol may be new to the United States, it has already been used for years in Europe, Canada, Australia, India, and many Asian markets under the trade name Tinosorb S.
What is Bemotrizinol?
Bemotrizinol (BEMT), commonly known as Tinosorb S, is an organic UV filter that provides broad-spectrum protection against both UVA and UVB radiation.
It is particularly valued because it:
- Protects against both UVA and UVB rays
- Is highly photostable
- Helps stabilize other UV filters
- Provides strong UVA protection
- Shows very low skin absorption
These characteristics have contributed to its widespread use in sunscreen formulations worldwide.
Why is the FDA approval important?
Historically, sunscreen formulators in the United States have had access to fewer UV filters than their counterparts in many other regions.
According to recent regulatory inventories:
- Europe authorizes approximately 34 UV filters
- Canada authorizes approximately 21–23 UV filters
- The United States authorized approximately 17 UV filters before the addition of Bemotrizinol
This difference has often limited formulation flexibility and made it more difficult to align US sunscreen products with formulas sold internationally.
The approval of Bemotrizinol expands the range of options available to sunscreen manufacturers.
New to the United States, Not New to the Rest of the World
Although the FDA approval received considerable attention, Bemotrizinol is not a new technology.
The ingredient has been used in sunscreen products for more than two decades in many regions, including:
- European Union
- Canada
- Australia
- India
- Several Asian markets
As a result, millions of consumers worldwide have already been using products containing Bemotrizinol for years.
The FDA approval therefore represents a regulatory change for the United States rather than the introduction of a completely new sunscreen ingredient.
Why did approval take so long?
The Bemotrizinol dossier has been closely followed by the sunscreen industry for many years.
The ingredient entered the FDA review process through the Time and Extent Application (TEA) pathway and has been under regulatory evaluation since 2018.
The approval follows the review of extensive safety and efficacy data submitted by industry stakeholders.
What does this mean for sunscreen manufacturers?
The approval creates new opportunities for companies developing sunscreen products for the US market.
Manufacturers may now be able to:
- Improve UVA protection
- Increase formulation photostability
- Reduce reliance on certain existing filters
- Better align US formulas with products sold internationally
However, reformulation, testing, and regulatory assessments may still be required before incorporating Bemotrizinol into existing products.
Does this bring the US closer to Europe?
While this approval is a major step forward, significant differences remain between sunscreen regulations in the United States and Europe.
The European Union continues to authorize a broader range of UV filters, while sunscreen products in the United States remain regulated under the FDA OTC Drug framework.
Nevertheless, the approval of Bemotrizinol may signal a gradual modernization of the US sunscreen regulatory landscape.
Frequently Asked Questions About Bemotrizinol
Is Bemotrizinol safe for skin?
Yes. Bemotrizinol has been used in sunscreen products in Europe, Canada, Australia, and Asia for over 20 years. Extensive safety evaluations have concluded that it is safe when used within approved conditions.
Which sunscreens contain Bemotrizinol?
Many sunscreen products sold outside the United States already contain Bemotrizinol. It is generally listed as Bemotrizinol on ingredient lists and may also be known under the trade name Tinosorb S.
Is Bemotrizinol available in Canada?
Yes. Bemotrizinol has already been authorized in Canada for several years and is included among permitted sunscreen medicinal ingredients.
Is Bemotrizinol better than zinc oxide?
Not necessarily. Zinc oxide and Bemotrizinol are different types of UV filters.
Zinc oxide is a mineral filter, while Bemotrizinol is an organic filter. Each offers advantages depending on the formulation objectives, desired SPF level, UVA protection profile, cosmetic elegance, and regulatory requirements.
Why is the FDA approval significant?
The approval is significant because it is the first new sunscreen active ingredient approved in the United States in more than two decades. It expands formulation possibilities and brings the US market closer to international sunscreen standards.
Related Resource
Interested in understanding how sunscreen regulations differ around the world?
Read our article:
Sunscreen Compliance: Comparing UV Filters and Testing Requirements Across the EU, US and Canada
Conclusion
The FDA approval of Bemotrizinol represents one of the most important sunscreen regulatory developments in recent years.
For manufacturers, it provides access to a UV filter that has already been widely adopted internationally while creating new opportunities for innovation and formulation optimization in the United States.
Need support with sunscreen compliance?
Whether you are evaluating new UV filters, reviewing sunscreen formulations, preparing product registrations, or assessing market requirements across the United States, Canada, and Europe, our regulatory experts can support your compliance strategy.
Contact our team to discuss your sunscreen compliance project.
➡️ Contact us
On June 17, 2026, the U.S. Food and Drug Administration (FDA) announced the approval of Bemotrizinol (BEMT) as a sunscreen active ingredient.
This marks a significant milestone for the US sunscreen industry, as it is the first new UV filter approved in more than 20 years.
While Bemotrizinol may be new to the United States, it has already been used for years in Europe, Canada, Australia, India, and many Asian markets under the trade name Tinosorb S.
What is Bemotrizinol?
Bemotrizinol (BEMT), commonly known as Tinosorb S, is an organic UV filter that provides broad-spectrum protection against both UVA and UVB radiation.
It is particularly valued because it:
- Protects against both UVA and UVB rays
- Is highly photostable
- Helps stabilize other UV filters
- Provides strong UVA protection
- Shows very low skin absorption
These characteristics have contributed to its widespread use in sunscreen formulations worldwide.
Why is the FDA approval important?
Historically, sunscreen formulators in the United States have had access to fewer UV filters than their counterparts in many other regions.
According to recent regulatory inventories:
- Europe authorizes approximately 34 UV filters
- Canada authorizes approximately 21–23 UV filters
- The United States authorized approximately 17 UV filters before the addition of Bemotrizinol
This difference has often limited formulation flexibility and made it more difficult to align US sunscreen products with formulas sold internationally.
The approval of Bemotrizinol expands the range of options available to sunscreen manufacturers.
New to the United States, Not New to the Rest of the World
Although the FDA approval received considerable attention, Bemotrizinol is not a new technology.
The ingredient has been used in sunscreen products for more than two decades in many regions, including:
- European Union
- Canada
- Australia
- India
- Several Asian markets
As a result, millions of consumers worldwide have already been using products containing Bemotrizinol for years.
The FDA approval therefore represents a regulatory change for the United States rather than the introduction of a completely new sunscreen ingredient.
Why did approval take so long?
The Bemotrizinol dossier has been closely followed by the sunscreen industry for many years.
The ingredient entered the FDA review process through the Time and Extent Application (TEA) pathway and has been under regulatory evaluation since 2018.
The approval follows the review of extensive safety and efficacy data submitted by industry stakeholders.
What does this mean for sunscreen manufacturers?
The approval creates new opportunities for companies developing sunscreen products for the US market.
Manufacturers may now be able to:
- Improve UVA protection
- Increase formulation photostability
- Reduce reliance on certain existing filters
- Better align US formulas with products sold internationally
However, reformulation, testing, and regulatory assessments may still be required before incorporating Bemotrizinol into existing products.
Does this bring the US closer to Europe?
While this approval is a major step forward, significant differences remain between sunscreen regulations in the United States and Europe.
The European Union continues to authorize a broader range of UV filters, while sunscreen products in the United States remain regulated under the FDA OTC Drug framework.
Nevertheless, the approval of Bemotrizinol may signal a gradual modernization of the US sunscreen regulatory landscape.
Frequently Asked Questions About Bemotrizinol
Is Bemotrizinol safe for skin?
Yes. Bemotrizinol has been used in sunscreen products in Europe, Canada, Australia, and Asia for over 20 years. Extensive safety evaluations have concluded that it is safe when used within approved conditions.
Which sunscreens contain Bemotrizinol?
Many sunscreen products sold outside the United States already contain Bemotrizinol. It is generally listed as Bemotrizinol on ingredient lists and may also be known under the trade name Tinosorb S.
Is Bemotrizinol available in Canada?
Yes. Bemotrizinol has already been authorized in Canada for several years and is included among permitted sunscreen medicinal ingredients.
Is Bemotrizinol better than zinc oxide?
Not necessarily. Zinc oxide and Bemotrizinol are different types of UV filters.
Zinc oxide is a mineral filter, while Bemotrizinol is an organic filter. Each offers advantages depending on the formulation objectives, desired SPF level, UVA protection profile, cosmetic elegance, and regulatory requirements.
Why is the FDA approval significant?
The approval is significant because it is the first new sunscreen active ingredient approved in the United States in more than two decades. It expands formulation possibilities and brings the US market closer to international sunscreen standards.
Related Resource
Interested in understanding how sunscreen regulations differ around the world?
Read our article:
Sunscreen Compliance: Comparing UV Filters and Testing Requirements Across the EU, US and Canada
Conclusion
The FDA approval of Bemotrizinol represents one of the most important sunscreen regulatory developments in recent years.
For manufacturers, it provides access to a UV filter that has already been widely adopted internationally while creating new opportunities for innovation and formulation optimization in the United States.
Need support with sunscreen compliance?
Whether you are evaluating new UV filters, reviewing sunscreen formulations, preparing product registrations, or assessing market requirements across the United States, Canada, and Europe, our regulatory experts can support your compliance strategy.
Contact our team to discuss your sunscreen compliance project.
➡️ Contact us
