Unlike many other markets where sunscreens are regulated as cosmetics, in the U.S. they are legally classified as over-the-counter (OTC) drugs because they are intended to prevent sunburn and reduce the risk of skin cancer and premature skin aging caused by ultraviolet radiation.

La U.S. Food and Drug Administration (FDA) ha publicado los fees aplicables para el año fiscal 2026 dentro del programa OMUFA (Over-the-Counter Monograph Drug User Fee Program), que afectan tanto a las instalaciones que fabrican medicamentos OTC bajo monografía como a las empresas que soliciten modificaciones en una monografía existente.

Understanding what qualifies as an OTC drug, how OTC monograph’s function, and what regulatory obligations apply is essential for companies planning to enter the U.S. market.

Understanding what the NDC Labeler Code is, who needs it, and how it interacts with other FDA identifiers is essential for successful market entry and compliance.

This regulatory move is part of a broader FDA effort to modernize the monograph system for over-the-counter drugs—including sunscreens—and promote scientific innovation in sun protection formulations. Although the proposal remains open for public comment until January 2026, its progress has already generated interest among formulators and dermatologists, who see bemotrizinol as a tool for delivering more effective formulations with an improved sensory profile.

Over-the-counter (OTC) products are one of the main areas where the US market differs from the rest of the world. A sunscreen, antiperspirant, or acne treatment may seem like simple cosmetics from a brand's international perspective, but for the FDA, they fall under the OTC ("over-the-counter") classification , which in the United States is regulated as drugs .

An OTC (Over-the-Counter) Monograph from the U.S. Food and Drug Administration (FDA) is the set of technical and legal requirements that allow an over-the-counter drug to be marketed without having to submit an individual New Drug Application (NDA).

The US is a very attractive market for the sale and export of cosmetic products. Big (and increasingly small) companies have aroused their interest in this market with more than 300M of potential consumers. However, some products that in Europe are considered as a cosmetics are considered drugs in the US under the Federal Drug Administration (FDA) rules. Among these drugs, those with a low risk to the user health are considered OTC (Over the Counter Drugs) and can be sold w