Expand The TFM addresses numerous aspects of sunscreen formulation and is comprehensive in nature. For instance, the TFM proposes what types of dosage forms sunscreens may be made in (e.g., sprays, lotions, etc.), what information must be included on the labeling, the maximum allowed value of the SPF, and requirements for using broad-spectrum claims. Additionally, one of the key areas that the TFM addresses are the active ingredients that may be used in sunscreens as UV filters. Previously, there were 16 permitted active ingredients for use in the United States. In the TFM, FDA identified two of the 16 ingredients, zinc oxide and titanium dioxide, as meeting FDA’s established conditions for safety and effectiveness. FDA requested that industry provide additional information on 12 ingredients currently used in sunscreens in the U.S. and around the world in order to support a generally recognized as safe and effective (GRASE) standard. Industry has committed to the FDA that we will work with the agency to provide information sufficient for them to conclude that the ingredients are GRASE.