UV Filter Ingredients
U.S. Food and Drug Administration (FDA)
The ultraviolet (UV) filters used as active ingredients in over-the-counter sunscreen drug products in the United States are regulated by the U.S. Food and Drug Administration. These ingredients must be shown to be safe and effective before they can be used. In addition, the UV filters that are used as sunscreen active ingredients can only be used as allowed by FDA in the applicable regulations.
Expert Panel for Cosmetic Ingredient Safety
UV filter ingredients that are used to protect products and packaging are often the same as those used for the formulation of sunscreen drug products. The safety of other UV filters has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel has considered the safety of many of the UV filters that are used in cosmetics and personal care products. In considering the safety of UV filters, the Expert Panel considers all the scientific data that is available, including data that is published in the peer-reviewed literature as well as information provided from other sources, and determines whether this information can allow a safety assessment. If additional information is necessary, the Expert Panel will issue a public announcement identifying the additional information that is needed to complete their safety assessment. When all of the information is available, the Expert Panel will then carefully review the data and issue a conclusion to the public. The conclusion can say that the ingredient is
(1) safe as used,
(2) safe with limitations on usage,
(3) unsafe and
(4) insufficient information to determine safety.
The Expert Panel conclusions provide important guidance for safe formulation of cosmetics and personal care products.
In Europe, the UV Filters that are used as active ingredients in sunscreen products are assessed and approved by the European Commission and listed in Annex VII of the Cosmetics Directive. As in the United States, these ingredients must be shown to be safe and effective before they can be used.