U.S. FDA guideline on sunscreen

In February 2019, the U.S. Food and Drug Administration (FDA) has issued a proposed rule that would update regulatory requirement for non-prescription over-the-counter sunscreens. It defines three categories for the active ingredient used in sunscreens, their labelling including sun protection factor (SPF) and broad-spectrum requirements and even considers their dosage forms. Here is a concise form of the proposed rule. The original released document by FDA can be found here. The proposed rule is FDA’s attempt to include modern science in defining the requirements for sunscreen as new active ingredients are developed by industry and consumers are applying sunscreens more often. Out of the 16 marketed active ingredients of sunscreens 2 ingredients are generally recognized as safe and effective (GRASE) and 2 are not GRASE due to safety issues. For the other 12 ingredients FDA asks for more information from industry and interested parties as the current information is insufficient to make a positive GRASE determination.

Active Ingredient
Generally Recognized as Safe and Effective (GRASE)
Zinc oxide
Titanium dioxide
PABA- Aminobenzoic Acid
Trolamine salicylate
When sunscreen is combined with insect repellents
Not determined due to insufficient data
Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octinoxate, Octisalate, Octocrylene, Padimate O, and Sulisobenzone, Oxybenzone and Avobenzone
FDA’s proposed rule also categorizes dosage forms and recognizes some as GRASE, but some like body wash and wipes are proposed to be considered as new drug. Powders are eligible for inclusion in monograph but if the requested data is provided. Categories of sunscreen dosage forms based on FDA’s proposed rule.

Dosage form
sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks
Conditionally eligible to be included
New Drug
Wipes, towelettes, body washes, shampoos
Furthermore, FDA proposes increasing the maximum sun protection value from SPF 50+ to SPF 60+ as consumers may not apply enough sunscreen that is required to achieve the nominal protection. A sunscreen with higher SPF value may provide better protection compared to for example SPF 30 in these cases. The proposed rule also defines SPF 80 as the maximum that can be marketed. FDA proposes broad-spectrum protection for sunscreens with SPF 15 or higher to provide protection against UVA in addition to UVB and proposes the higher the SPF value the better the broad-spectrum protection as consumers expect better protection against both UVA and UVB from products with high SPF values and not only UVB.