The FDA has revised and finalized its previously issued (2011) Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry.  FDA notes that “this guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective.”  The Agency also indicates that several rulemaking activities will also be initiated that will address these products.

The guidance spends considerable time describing the past activity leading up to the current guidance and the history of the rule-making activities that will hopefully lead to the finalization of the OTC monograph for sunscreen products.

The document describes those ingredients, as well as the types of dosage forms that are likely to be included in the final monograph, and discusses the required testing and labeling requirements that will keep the FDA from taking enforcement action against products marketed without approval.

The 2011 final rule outlined four 4 items that would render sunscreen products misbranded which include:

  • Claims in labeling or promotional materials that suggest or imply that the use, alone, of any sunscreen reduces the risk of or prevents skin cancer or early skin aging (§ 201.327(c)(3))
  • Claims such as “sunblock,” “sweatproof,” and “waterproof” (§ 201.327(g))
  • Claims for instant protection or protection immediately upon application (21 CFR


  • Claims for “all-day” protection, or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in § 201.327 (§ 310.545(a)(29)(ii))

In the final guidance, FDA notes that it does not intend to take regulatory action if all of the following apply:

  • Contain as sunscreen active ingredients only the active ingredients or combinations of active ingredients listed in section II., Background (previously included in 21 CFR 352.10 and 352.20, which are now stayed)
  • Do not make claims addressed in §§ 201.327(c)(3) and (g) and 310.545(a)(29)(ii)
  • Comply with the requirements for OTC drugs under 21 CFR part 201 and 21 CFR 330.1, requirements for adverse event reporting for OTC drugs in the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379aa), and provisions of the FD&C Act addressing adulteration
  • Follow applicable labeling and testing requirements for OTC sunscreens in § 201.327 except as specific recommendations of this guidance address

In addition, there is guidance on broad spectrum testing, SPF testing, products labeled with SPF values higher than 50, and acceptable dosage forms for sunscreen products that must be met in order to avoid enforcement action.  There are also specific warnings for spray products that must be included for that specific dosage form.

The following dosage forms are NOT eligible for enforcement discretion:

  • Wipes
  • Towelettes
  • Powders
  • Body washes
  • Shampoos

Finally, the document discusses sunscreen products with insect repellents and outlines products not covered by the enforcement discretion policy.  A complete copy of the final guidance can be found here. Make certain your firm understands how the policy will be implemented so you don’t get caught in the dark!