COVER STORY: PARSOL® Shield FDA-approved: A new era for US sun protection

For decades, the US sun care market has evolved under a unique tension: rapidly shifting consumer expectations on one side, and a relatively static set of approved UV filters on the other. While beauty routines have become more sophisticated—prioritizing sensorial elegance, daily usability, and multifunctional performance— the regulatory framework has often limited how far formulators and brands could innovate.

That reality is now changing

With the FDA approval of PARSOL® Shield, the first new sunscreen active in more than 25 years enters the US market, introducing a new level of technical capability and creative freedom for brands. More importantly, it signals a broader reset— one that aligns US sun care more closely with global innovation trends and evolving consumer expectations.

As the President and CEO of the Personal Care Products Council (PCPC) Tom Myers emphasised: “We applaud FDA for advancing this long-awaited decision.”

Consumer awareness around sun exposure has never been higher. Beyond sunburn, consumers increasingly understand the links between UV radiation, premature aging, and long-term skin health risks. At the same time, expectations around product experience have fundamentally shifted.

Today’s sunscreen must do more than protect—it must integrate seamlessly into skincare routines, feel lightweight, work across diverse skin tones, and support everyday wear.

This convergence of health awareness and beauty expectations has created a clear need: higher-performing UV filters that enable both advanced protection and elevated product design. 

As noted by David Andrews, Ph.D., chief science officer at Environmental Working Group: “This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in US sunscreens”.

What sets PARSOL® Shield apart is not only its broad-spectrum protection performance, but the pathway taken to bring it to market. Its approval reflects years of scientific substantiation, regulatory engagement, and close alignment with the FDA’s evolving standards.

The process included the first Maximal Usage Trial conducted under updated FDA guidelines and the submission of a Tier 1 Monograph Order Request—marking a new benchmark for how sunscreen innovation can be introduced into the US regulatory system.

This milestone is widely recognized across stakeholders, regulators and scientists alike. The significance of this milestone lies in the journey: a rigorous, science-led approval process guided by an entirely in-house strategy at dsm-firmenich, under the leadership of Industry Regulatory Affairs experts, Jochen Klock and Carl D’Ruiz.

The result is more than a new ingredient—it is proof that scientific rigour, regulatory compliance, and meaningful innovation can coexist within the US framework.

For years, the global sunscreen landscape has been uneven. Markets outside the US have had access to a broader range of UV filters, enabling more advanced formulations and more sophisticated product experiences. In contrast, US brands have operated with a narrower toolkit, often facing formulation trade-offs and limitations on sensorial performance.

PARSOL® Shield plays a critical role in closing that gap

As Jochen Klock, Sr. Director, Global Regulatory Affairs, Beauty & Care, explains, “This approval closes a longstanding innovation gap in the US sunscreen market and establishes a modern scientific and regulatory benchmark for what advanced sun protection can look like”.

By enabling access to a new generation of UV technology, the approval reinforces the idea that the US market can once again be a leader in sun care innovation—not an outlier.

From a formulation standpoint, PARSOL® Shield introduces meaningful benefits. It is positioned as a highly efficient broad-spectrum UV filter, delivering strong UVB and UVA performance even at relatively low concentrations.

This efficiency has direct implications for formulators. Lower concentration requirements can reduce formulation complexity, while compatibility with both organic and inorganic filters enables greater flexibility. Strong photostability further supports consistent protection over time.

Formulation and sensorial design 

Equally important is the impact on sensorial  design. In a category where consumer adoption is closely tied to product feel, the ability to deliver lighter textures and more elegant finishes is critical. This is where the ingredient connects directly to consumer behaviour: better-feeling products drive more consistent use, reinforcing both brand value and public health outcomes.

As Pennsylvania Congressman John Joyce, M.D., noted: “As a board-certified dermatologist and now a physician-legislator, I understand the critical role sunscreen plays in preventing melanoma and other forms of skin cancer.

“With bipartisan support, I was proud to advance the SAFE Sunscreen Standards Act to ensure that the FDA quickly approves new sunscreen ingredients. The approval of this new sunscreen filter marks an important step forward in expanding access to innovative sun protection and helping Americans better protect themselves from harmful UV exposure.”

For marketers and business leaders, the significance of PARSOL® Shield extends well beyond formulation. Today’s sun care category is increasingly defined by premiumization, multifunctionality, and experiential value. Products must combine clinical credibility with emotional engagement—delivering not only efficacy, but also pleasure, trust, and ease of use.

As Tina Vogt, Director, Global Marketing Sun Care, explains: “Today’s consumers expect more from sunscreens — high protection, beautiful aesthetics, and textures they actually want to wear every day. PARSOL® Shield helps brands deliver all three”.

This alignment between science and experience creates a powerful platform for differentiation. Brands can build narratives that go beyond protection—focusing on lifestyle integration, wellbeing, and long-term skin health. 

Carl D’Ruiz, Sr. Business Development Manager, Beauty & Care North America, frames the opportunity clearly: “For US brands, this is more than a regulatory milestone. It is a commercial and formulation opportunity to lead with a modern UV filter that answers real consumer needs while accelerating innovation.”

Another key advantage lies in global harmonization

PARSOL® Shield is already established in multiple regions, enabling more consistent formulation strategies across markets. For multinational brands, this reduces fragmentation across development pipelines and supports more efficient innovation. It can streamline processes, reduce time to market, and enable stronger cross-market consistency—critical advantages in a highly competitive category.

Beyond performance, PARSOL® Shield aligns with the growing emphasis on responsible and future-fit formulation. Its profile supports the development of more conscious sunscreen solutions, reinforcing its relevance in a market increasingly shaped by sustainability expectations.

Its credibility is further supported by robust clinical substantiation. Studies involving nearly 500 participants demonstrated high UV efficacy, excellent tolerability, and strong safety profile— key factors in building trust among regulators, brands, and consumers alike.

The broader public health dimension adds further depth to the story. As the President of The Skin Cancer Foundation Deborah S. Sarnoff, MD, stated: “The Skin Cancer Foundation applauds the US Food and Drug Administration for approving bemotrizinol [PARSOL® Shield] for use in the American market.

“Nearly 90 percent of all skin cancers are preventable with a complete sun protection strategy, but American adoption of sun-safety practices is low. We need to do everything we can to help improve American sun protection behaviours.”

Ultimately, PARSOL® Shield arrives at a moment when the industry is asking critical questions. How can sun care deliver stronger protection without compromising aesthetics? How can products better integrate it into everyday routines? And how can brands meet rising expectations while maintaining trust and credibility?

PARSOL® Shield provides a compelling answer

As Parand Salmassinia, President, Beauty & Care at dsm-firmenich, puts it: “PARSOL® Shield represents an important step forward not only for dsm-firmenich, but for the future of sun protection in the US. This milestone reflects years of scientific leadership, regulatory collaboration, and commitment to bringing meaningful innovation to consumers.”

More broadly, it marks a shift in mindset. Sun care is no longer solely about compliance or basic protection—it is about delivering products that consumers genuinely want to use, every day.

Conclusion

The approval of PARSOL® Shield is a pivotal milestone—but it is also the starting point for a new phase of innovation in US sun care. For brands ready to act, the opportunity is clear: to redefine product portfolios, elevate consumer experiences, and lead a category that is finally catching up with global expectations.

PARSOL® Shield is not just a new ingredient— it signals the beginning of a new era for American sun protection. Discover how you can join the sun care revolution in the US.

dsm-firmenich Beauty & Care
P.O.Box 2676, CH-4002 Basel, Switzerland
Tel: +41 61 815 88 88
Email: beautycare.communications@dsm firmenich.com
Website: www.dsm-firmenich.com

 

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