Kimberly Norman of PCPC on Modernizing Sunscreen Safety Assessment and Accelerating Innovation in the U.S

Interview with Kimberly Norman, PhD, DABT, ERT,
Senior Director, Safety and Regulatory Toxicology, Personal Care Products Council (PCPC)

You recently participated in our Skin/Sun Care webinar on modernizing sunscreen safety assessment and accelerating innovation in the United States. For our European readers, why are sunscreens classified as over-the-counter (OTC) drugs in the United States?

Unlike many countries where sunscreens are regulated as cosmetics, U.S. law classifies them as over-the-counter (OTC) drugs because they are intended to prevent disease and affect the structure or function of the body. Specifically, sunscreens are intended to help prevent sunburn and decrease the risk of skin cancer and early skin aging caused by the sun. These are drug claims under the U.S. Food, Drug, and Cosmetic Act. In addition, sunscreen active ingredients (UV filters) affect how the body responds to ultraviolet (UV) radiation by absorbing, reflecting, or scattering UV rays before they can damage the skin. This classification has important implications for both innovation and regulation, as sunscreen active ingredients must meet the safety and effectiveness standards established under the FDA’s OTC drug framework.

What significant regulatory milestones have shaped sunscreen safety assessment in the United States?

Several important milestones have defined the current U.S. sunscreen regulatory landscape:

• 1978: FDA proposed the first sunscreen monograph and reviewed 21 UV filters for safety and effectiveness.
• 1999: FDA issued the final sunscreen monograph recognizing 16 UV filters.
• 2014: The Sunscreen Innovation Act was enacted to provide a pathway for reviewing additional sunscreen active ingredients.
• 2019: FDA issued a proposed rule that updated its thinking on sunscreen safety assessments and data requirements.
• 2025: The SAFE Sunscreen Standards Act was signed into law, directing FDA to modernize aspects of its sunscreen review process.
• 2026: Bemotrizinol became the first new sunscreen active ingredient added to the U.S. OTC sunscreen monograph in more than 25 years

What do the available data tell us about the safety of established organic UV filters?

A substantial body of scientific evidence has accumulated for many established organic UV filters commonly used in formulations in the US (avobenzone, octocrylene, octisalate, homosalate, octinoxate, ensulizole), including both pre-market data and safe use by consumers for decades.

Key conclusions include:

• No evidence of genotoxicity.
• No biologically relevant carcinogenic modes of action have been demonstrated.
• Human exposure levels are substantially below concentrations associated with biological activity in laboratory studies.
• Extensive real-world use and post-market experience continue to support their safe use when formulated and used as intended.

What challenges has the FDA's approach created for sunscreen innovation?

One of the greatest challenges has been the reliance on traditional toxicology requirements, including requests for long-term animal studies for carcinogenicity and developmental and reproductive toxicology.

While these studies have historically been part of regulatory safety assessments, the rodent bioassays are not the best approach for predicting human risk, particularly for topical ingredients with low systemic exposure. As toxicology evolves, there is increasing interest in applying New Approach Methodologies (NAMs), including in vitro systems, computational models, exposure-based assessments, and Next Generation Risk Assessment (NGRA) frameworks that may provide more human-relevant information while reducing reliance on animal studies.

What opportunities exist to modernize sunscreen regulation and safety assessment?

Several developments create opportunities for modernization:

• The approval of bemotrizinol demonstrates that progress is possible.
• Scientific advances in NAMs and NGRA offer more human-relevant approaches to safety assessment.
• Growing international experience provides valuable real-world evidence for well-established ingredients.
• New legislation and regulatory initiatives are encouraging FDA to consider more flexible and science-based approaches.

Ultimately, modernization should maintain FDA's high standards for safety while enabling innovation to reach consumers more efficiently.

How could the SAFE Sunscreen Standards Act help modernize sunscreen safety assessment in the United States?

The SAFE Sunscreen Standards Act represents one of the most important policy developments in sunscreen regulation in recent years. The legislation encourages FDA to incorporate modern scientific tools and evidence streams when evaluating topical active ingredients, including sunscreens. Among other provisions, it supports consideration of real-world evidence, historical safety data, and non-animal approaches.

For scientists, regulators, and consumers alike, the legislation signals a shift toward a more modern, evidence-based model of sunscreen safety assessment.

What are PCPC's priorities for advancing sunscreen innovation and regulatory modernization?

PCPC remains committed to supporting science-based regulatory modernization that protects public health while encouraging innovation.

Our priorities include:

• Advancing the acceptance and regulatory application of New Approach Methodologies (NAMs).
• Supporting development of Next Generation Risk Assessment frameworks for sunscreen ingredients.
• Working collaboratively with FDA, policymakers, and other stakeholders to implement the SAFE Sunscreen Standards Act.
• Building on the momentum created by bemotrizinol's approval to facilitate access to additional sunscreen innovations.
• Continuing to generate and publish scientific evidence that supports modern, human-relevant approaches to safety assessment.

At the end of the day, our goal is simple: ensure consumers have access to safe, effective, innovative sun protection products that help reduce the burden of skin cancer while reflecting the best available science.

Personal Care Products Council | PCPC