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FDA Issues Proposed Rule on Final Monograph for OTC Sunscreen Products

On February 26, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish final monograph regulations for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.

Since issuing an indefinite stay on a 1999 final monograph, FDA has mostly regulated Sunscreen products under enforcement discretion.  In 2011, FDA clarified its enforcement approach to OTC sunscreen products through a draft guidance that was later finalized in 2018.  At that point in time, FDA also issued a final rule for the labeling of OTC sunscreen drug products and established mandatory parameters for broad spectrum, sun protection factor (SPF) and water resistance testing. This final rule was codified in 21 CFR 201.327.

FDA’s new proposed rule would lift the stay on the 1999 final monograph as well as establish the following major provisions:

GRASE Status of Sunscreen Active Ingredients

The rule proposes that zinc oxide and titanium dioxide remain classified as generally recognized as safe and effective (GRASE) for use in sunscreens at concentrations of up to 25 percent.

Aminobenzoic acid and trolamine salicylate would be classified as not GRASE for use in sunscreen as FDA has determined the risks posed by these ingredients outweigh their benefits.  Drug products containing non-GRASE ingredients are considered misbranded and prohibited from being marketed in the U.S.

Additionally, the rule proposes that the following twelve ingredients would be excluded from the final monograph because there is insufficient data to determine whether they are GRASE:

  • Cinoxate
  • Dioxybenzone
  • Ensulizole
  • Homosalate
  • Meradimate
  • Octinoxate
  • Octisalate
  • Octocrylene
  • Padimate O
  • Sulisobenzone
  • Oxybenzone
  • Avobenzone

Many of these ingredients are considered GRASE under the 1999 monograph, meaning sunscreen products with these ingredients can currently be marketed without a new drug application (NDA). If FDA’s new proposed rule becomes final, sunscreen products with these ingredients may not be introduced into interstate commerce one year after the final rule becomes effective. FDA has proposed an effective date for the final rule of November 26, 2019.

GRASE Statuses of Sunscreen Dosage Forms

The rule proposes to classify oils, lotions, creams, gels, butters, pastes, ointments, and sticks as GRASE dosage forms for sunscreens.  Sprays would also be GRASE, contingent on testing to minimize risks from inhalation (particle size restrictions) and flammability (flammability and drying time testing).

Sunscreens in powder form would be eligible for inclusion in the final monograph pending additional scientific data supporting their safety.  Powder sunscreens would also be subject to the same particle size restrictions as sprays.  Other dosage forms, such as wipes, body washes, and shampoos would be considered new drugs, which require FDA approval of an NDA to market in the U.S.

Changes to Sunscreen Labeling

The rule proposes to require a sunscreen’s statement of identity to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”).  The rule would also revise format requirements to make SPF, broad spectrum, and water resistance statements more prominent on a product’s principal display panel (PDP). Products that do not meet broad spectrum requirements must also include an asterisk next to the SPF value and an associated statement “*See Skin Cancer/Skin Aging Alert.”

Due to evidence showing “additional meaningful clinical benefit” from broad spectrum sunscreen products with an SPF of 60, the rule proposes to increase the maximum SPF displayed on sunscreen labels from 50+ to 60+.  Sunscreen manufacturers would still be permitted to market products formulated up to 80 SPF as OTC.

Additionally, all sunscreen products over 15 SPF would be required to satisfy broad spectrum labeling and testing requirements.  Among the other requirements of broad spectrum testing, the rule proposes that these products must meet a UVA I/UV ratio of 0.7 or higher.

Prohibition of Sunscreen-Insect Repellent Combinations

Given their use as pesticides, sunscreen-insect repellent combination products are also regulated by the Environmental Protection Agency (EPA).  FDA has determined that these products cannot be labeled to “sufficiently ensure safe and effective use of the sunscreen component and provide adequate directions for use” due to incompatibility with EPA labeling requirements.  The rule proposes to classify these products as not GRASE, which would effectively prohibit them from being marketed in the U.S.

What Industry Should Expect

FDA’s new proposed rule brings some significant possible changes for the sunscreen industry.  As with any proposed rule, these provisions are not final; however, they illustrate FDA’s current thinking for the direction of sunscreen regulations.  Sunscreen companies should familiarize themselves with the 1999 final monograph (21 CFR Part 352), required labeling based on effectiveness testing for OTC sunscreen drug products (21 CFR 201.327), and the newly proposed rule to prepare for compliance.

Registrar Corp assists sunscreen companies with FDA compliance.  Our Regulatory Specialists can register your establishment and list your products with FDA, serve as your U.S. Agent, review your sunscreen’s labeling for compliance, and more.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.