FDA Announces Administrative Action Requiring Safety Data for 12 OTC Sunscreen Products, Including Brands from Kenvue and Edgewell
Background of the Transition to an Administrative Order System for OTC Monographs Under the CARES Act
The U.S. Food and Drug Administration (FDA) transitioned the over-the-counter (OTC) sunscreen monograph system to an administrative order system pursuant to Section 3854 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted in 2020. The existing multi-tiered rulemaking process had delayed the approval of new UV absorbers for decades, but this shift in the executive order framework has enabled faster regulatory enforcement based on scientific safety data. The FDA is maintaining existing requirements on a temporary basis through its Deemed Final Order while actively advancing proposed revisions that reflect modernized efficacy and safety verification standards. This goes beyond mere administrative procedural adjustments, serving as a regulatory inflection point that fundamentally reshapes the entry barriers for the U.S. premarket approval market, which exceeds $3 billion annually.
Reclassification of GRASE Active Ingredients and the Dominant Position of Mineral Filters
The FDA has officially recognized only two types of mineral filters, Zinc Oxide and Titanium Dioxide, as 'Generally Recognized as Safe and Effective (GRASE Category I)' among the 16 active sunscreen ingredients currently on the market. Two previously widely used ingredients, PABA and Trolamine Salicylate, were ultimately classified as Category II, excluding them from GRASE due to safety concerns. Consequently, major beauty and pharmaceutical companies such as Kenvue (KVUE) and L'Oréal (OR) are rapidly expanding their portfolios of high-margin premium dermacosmetic products featuring mineral sunscreens. As a result, mineral-based formulations, free from raw material toxicity controversies, have established a firm position as the safety standard in the North American market.
Regulatory Risks of 12 Organic Filters in MUsST Clinical Pharmacokinetic Trials
Twelve types of organic (chemical) filters, including avobenzone, oxybenzone, and octinoxate, are classified as Category III, requiring additional safety data and undergoing clinical re-evaluation. In the Maximal Usage Trial (MUsST) clinical study led by the FDA, it was confirmed that these organic chemical ingredients are absorbed into the bloodstream, significantly exceeding the FDA's toxicological concern threshold of 0.5 ng/mL. While regulatory authorities have not issued a sales ban, they are strongly demanding that the manufacturer consortium submit extensive non-clinical and clinical data, including systemic absorption pharmacokinetics (PK), carcinogenicity, and endocrine disruption assessments. As regulatory compliance costs surge, the pressure for reformulation is intensifying for mass-market brands, including Edgewell Personal Care (EPC).
Global Supply Chain Restructuring and the Entry of Next-Generation Optical Filters into the U.S. Market
This regulatory Q&A reaffirms that the burden of proof for safety lies entirely with manufacturers, thereby triggering restructuring of product pipelines for global raw material suppliers and finished goods manufacturers. The shifting landscape within the market is becoming apparent as next-generation photostable optical filters, such as bemotrizinol (Bemotrizinol, BEMT), which have been extensively validated in Europe and Asia for over 20 years, push for inclusion in the US OTC monograph. Global chemical companies such as BASF and DSM-Firmenich are investing large amounts of R&D capital into approving new molecules to replace existing chemical filters facing regulatory uncertainty. Ultimately, the FDA's stringent data requirements are expected to further consolidate market concentration among global top-tier companies with long-term regulatory compliance capabilities and capital strength.
The US sunscreen market is projected to reach approximately $3 billion annually by 2026 (with a global market of $16 billion), and the FDA's administrative order amending the OTC monograph introduces direct volatility into the formulation redesign costs and supply chain margin structures for dominant market players such as KVUE, EPC, and L'Oréal (OR). In the short term, formulation R&D expenditures are expected to surge and market exit of companies with regulatory compliance limits is accelerating due to the burden of submitting MUsST clinical pharmacokinetic and chronic toxicity data for 12 types of organic chemical filters whose systemic absorption blood concentrations exceed 0.5 ng/mL. In the long term, the market share of inorganic mineral UV filters based on zinc oxide and titanium dioxide will expand to over 40%, while a generational shift centered on next-generation photostable filters, such as BEMT (Bemotrizinol), which is attempting its first entry after about 30 years, will fully commence. From the perspectives of researchers and industry, the design of polymer filters that inhibit systemic circulation absorption and the capability for nonclinical endocrine toxicity assessment have emerged as key benchmarks determining commercial success or failure.