The essentials
FDA approves bemotrizinol, the first new sunscreen ingredient approved in 25 years.
The FDA has approved bemotrizinol as the first new sunscreen ingredient in over 25 years, marking a significant expansion in sun protection options available to consumers. The ingredient will be marketed under the brand name Parsol Shield by DSM Nutritional Products.
This approval is historic in its regulatory pathway: bemotrizinol is the first ingredient approved under a streamlined FDA review process implemented in 2020. The new procedural framework was designed to accelerate the evaluation of sunscreen components, potentially paving the way for additional approvals in the coming years. The approval reflects the FDA's efforts to modernize how it evaluates over-the-counter sunscreen ingredients, which had remained largely unchanged since the late 1990s.
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Streamlined Process Delivers First New Sunscreen Ingredient Since Late 1990s
Bemotrizinol's approval demonstrates the FDA's 2020 streamlined review process in action, delivering the agency's first new sunscreen ingredient in 25 years. The regulatory pathway change was designed to accelerate ingredient evaluation, and this approval confirms the framework's efficacy in moving promising formulations through review more efficiently than traditional methods.
DSM Launches Parsol Shield as Expanded Sun Protection Portfolio
DSM Nutritional Products now brings bemotrizinol to market under the Parsol Shield brand, expanding consumer sun protection options after a quarter-century without new ingredient approvals. The ingredient's market entry represents a commercial opportunity in the sunscreen sector and reflects renewed regulatory capacity to evaluate novel protective compounds.