Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health.

BACKGROUND

Skin cancer is the most common cancer in the United States, with over 5 million cases diagnosed annually. Despite being largely preventable, incidence rates continue to rise, largely due to inadequate protection from ultraviolet (UV) radiation, the primary environmental cause of skin cancer. Although global innovation has advanced sunscreen technology, the U.S. regulatory system has not kept pace, limiting public access to more effective UV filters.

METHODS

This review examines the current U.S. Food and Drug Administration (FDA) sunscreen filter regulatory framework, including the Generally Recognized As Safe and Effective (GRASE) criteria and maximal usage trial (MUsT) protocols. We compare U.S. approved filters with newer filters used internationally and analyze barriers to their domestic approval.

RESULTS

International markets currently use advanced filters such as bemotrizinol, bisoctrizole, drometrizole trisiloxane (DT), and terephthalylidene dicamphor sulfonic acid (TDSA), which offer broader and more stable UV protection. These filters have demonstrated favorable safety and efficacy profiles but remain unavailable in the U.S. due to regulatory inertia. The FDA's new Over-the-Counter (OTC) Monograph Order Request (OMOR) process may provide a pathway to modernize sunscreen regulations.

CONCLUSION

Modernizing U.S. sunscreen regulations to allow approval of newer, evidence-backed UV filters is a critical step in improving public health. Broader access to more effective sunscreens could play a significant role in reducing the incidence of UV-induced skin cancer.