Abstract
The FDA’s recent bemotrizinol decision represents more than the introduction of a new UV filter. It signals a broader modernization of sunscreen evaluation through the integration of New Approach Methodologies (NAMs), real-world evidence (RWE), and structured weight-of-evidence (WoE) frameworks. Using bemotrizinol as a case study, this presentation examines how physiologically based pharmacokinetic modeling, in silico toxicology, mechanistic assays, dermal absorption data, and decades of global experience can be combined to characterize safety, exposure, and biological relevance with greater scientific precision. Beyond enabling bemotrizinol, the OMOR pathway establishes a blueprint for evaluating future UV filters, novel dosage forms, internationally recognized ISO efficacy methodologies, and next-generation sunscreen claims using integrated evidence streams. This emerging framework can accelerate formulation innovation, strengthen claims substantiation, support global scientific harmonization, and expand access to advanced photoprotective technologies, creating a modern, evidence-driven pathway for sunscreen innovation that extends far beyond a single active ingredient.