US FDA Proposes Changes to Rules for Over-the-Counter Sunscreen Products
05/04/2019

The US FDA has issued a proposal to update the regulations covering over-the-counter sunscreen products.

Online PR News – 04-May-2019 – Geneva, Switzerland – The US Food and Drug Administration (FDA) has issued a proposal to put into effect a final monograph and update the regulatory requirements covering over-the-counter (OTC) sunscreen products.

Published on February 21, 2019, the proposed rule includes several endpoints of OTC sunscreens that will ensure easy identification of key characteristics. These include:
• Safety of active ingredients
• Dosage forms
• SPF and broad-spectrum requirements
• Testing changes
• Record keeping obligations
• Labeling requirements

The proposed rule also identifies two active ingredients that are Generally Recognized as Safe and Effective (GRASE):
• Zinc oxide
• Titanium dioxide
And two that are not, due to safety concerns:
• Aminobenzoic acid
• Trolamine salicylate

Stakeholders should be aware the FDA has so far not made a GRASE determination on:
• Cinoxate
• Dioxybenzone
• Ensulizole
• Homosalate
• Meradimate
• Octinoxate
• Octisalate
• Octocrylene
• Padimate O
• Sulisobenzone
• Oxybenzone
• Avobenzone

The FDA has requested more data on these substances to make a determination and has published guidance to ensure companies understand the requirements necessary for a GRASE determination.

The proposal also considers GRASE dosage forms to include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks, but excludes wipes, towelettes, body washes, shampoos and other forms which would be categorized as new drugs, due to a lack of data at this time. Powders are currently listed as needing additional safety/efficacy data to support a GRASE determination, with sprays and powders having specific particle size requirements.

Other proposed 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

Finally, the proposal includes changes to final product testing and record keeping. 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-MED) 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

Stakeholders should be aware that existing OTC sunscreen products can remain on the market while the proposals are considered and public comment is sought. It is expected that a final rule on sunscreen monographs will be produced by late November 2019.

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