The OTC Monograph specifies the active ingredients and their permitted concentrations for each category of OTC products. In the U.S., OTC (Over-the-Counter) drugs are regulated by the FDA under the OTC Monograph System.T he Sunscreen Drug Products for Over-the-Counter Human Use is included in the FDA OTC Monographs which outlines the active ingredients that are generally recognized as safe and effective for use in OTC sunscreen products.

US FDA OTC durg registration

USA-The FDA Monograph Ingredients (OTC) (Sunscreen active ingredients)

USA-The FDA Monograph Ingredients(OTC) (Sunscreen active ingredients)

Maximum concentration in ready for use preparation