Food and Drug Administration (FDA) Proposes New Rule for Sunscreen Products

From the Food and Drug Administration

As a continued part of the Food and Drug Administration (FDA) and their effort to regulate over the counter (OTC) products, a proposed rule was issued to amend the monograph for OTC sunscreen products. This rule addressed the formulation, labeling and testing requirements for UVA and UVB radiation protection.

The proposed changes affect the ingredients, the sun protection factor labeling, the UVA and UVB labeling and testing, the warnings, indications and the directions. Of note, regarding ingredients, the allowable combinations of active ingredients will now include avobenzone with zinc oxide and avobenzone with ensulizole.

In terms of labeling changes, SPF values may be permitted up to, but not exceeding 50. Any OTC sunscreen with a SPF of over 50 will be labeled as “50+.” Rather than using the term “sun protection,” the phrase will now be, “sunburn protection.” Additionally, UVB must be included before “SPF” on the principal display panel. Further, a product category description will be included on the display label to indicate the standard public health message about the use of sunscreen. Category descriptors will be termed as, “low” and “medium.” Also on the label, the level of UVA protection will be designated as: low, medium, high or highest. This UVA categorization will be included as an additional product indication.

Another change will be on the warning label. There will be an updated “sun alert” statement on all OTC sunscreen products, excluding lip cosmetic and lip protection products. The statement is intended to warn users to decrease UV exposure as a way to reduce risk of skin cancer, premature aging and other skin damage. Further, the directions will be amended to require the term, “liberally” or “generously,” as to encourage users to apply the correct amount of sunscreen.

Lastly, there will be new standards in UVB and UVA testing. For UVB testing a padimate O/oxybenzone standard will replace the current spectrophotometric method. As for UVA testing, a combination of in vitro and in vivo procedures will be used.

These new measures were developed in response to public comment and new data. As these changes are significant, the FDA anticipates over one year may be required to implement the new product labeling and testing procedures.

Visit www.fda.gov for additional information.

No reprints available.