FDA Issues Small Business Guidance on OTC Sunscreen Labeling

A new guidance is available for small business compliance with labeling and testing requirements for over-the-counter sunscreen drug products, said the Food and Drug Administration. The guidance summarizes FDA’s June 17, 2011 final rule on the subject, which: (i) required that OTC sunscreen drug products follow Drug Facts labeling content and format requirements; (ii) Established new labeling requirements for marketed OTC sunscreen drug products; and (iii) Revised SPF, broad spectrum, and water-resistant testing requirements and the indications and claims allowed based upon the results of these tests.