The US FDA has issued a proposed rule to put into effect a final monograph for OTC sunscreen drug products, recognizing two ingredients as GRASE, two ingredients as not GRASE, and asking for additional data on a further 16 active ingredients.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 058/19

Hands of a female holding sunscreen at the beach

On February 21, 2019, the FDA issued a proposed rule to update regulatory requirements for over the counter (OTC) sunscreen products marketed in the United States.

The proposed rule includes several endpoints of OTC sunscreens to ensure ease in identifying key characteristics of marketed products, including:

  • Safety of active ingredients
  • Dosage forms
  • SPF and broad-spectrum requirements
  • Testing changes
  • Record keeping obligations
  • Labeling requirements

The proposed rule indicates two active ingredients, zinc oxide and titanium dioxide, Generally Recognized as Safe and Effective (GRASE) for use in OTC sunscreens. It also informs that two ingredients, aminobenzoic acid and trolamine salicylate, are not GRASE for use, due to safety concerns.

The FDA has yet to make a GRASE determination on the remaining 12 ingredients, citing insufficient safety data to make a determination at this time. The FDA has asked for additional data, as well as published guidance to ensure companies understand the requirements necessary for a GRASE determination. The 12 ingredients include:

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

In addition to updating the status of active ingredients, the proposed rule attempts to clarify several other areas. The proposal considers GRASE dosage forms to include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks. Excluded at this time are wipes, towelettes, body washes, shampoos and other forms which would be categorized as new drugs due to a lack of existing data. Powders are listed as needing additional safety/efficacy data to support a GRASE determination. Sprays and powders will have particle size requirements.

Other changes include:

  • Raising the maximum SPF value on labels from 50+ to 60+
  • Setting a maximum formulation requirement of SPF 80 before NDA is necessary
  • Requiring sunscreens with SPF value of 15 or higher to provide broad spectrum protection
  • Requiring broad spectrum products to provide additional protection as SPF value increases
  • Adding active ingredients to the front of the package
  • Considering combination sunscreen and insect repellant products as not GRASE

Several proposed changes related to final product testing and record keeping were also made. Amongst the most significant are:

  • Products of SPF 15 and higher should be labeled with an SPF number corresponding to the lowest number in a range of tested SPF results
  • Adding a ratio requirement to the in-vitro broad spectrum testing criteria
  • The new definition of responsible person and calling for said person(s) to keep certain sunscreen records
  • Requiring additional documents to be available for FDA inspection
  • Requiring a Preliminary Unprotected MED (Pre-MEDu) not greater that one day prior to testing
  • Revisions to test subject’s informed consent and IRB approval of research
  • Registration for the establishment conducting the final formulation test
  • Revising so that SPF clinical studies should not include individuals who’ve had UV exposure or participated in another SPF clinical study for at least the past four weeks or longer if certain conditions are present

Next Step:

OTC sunscreen products will continue to remain on the market as the rulemaking proceeds.

The FDA is also seeking public comment on the proposed rule as it develops its final rule for the product type. The final rule on sunscreen monographs is expected late November 2019, as required by the Sunscreen Innovation Act.

Source of Information:

[1] FDA News Release on February 21, 2019
[2] Proposed Rule on Sunscreen Drug Products for Over-the-Counter Human Use

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