Sunscreen Drug Products for Over-the-Counter Human Use (Proposed Rule)

Policy Details

Policy Details

Last Action
Date of Last Action
Apr 18 2019
Date Introduced
Feb 26 2019
Publication Date
Feb 27 2019
Date Made Public
Feb 26 2019

SciPol Summary

The FDA is proposing to put into effect the final monograph on over-the-counter (OTC) sunscreen drug products. An OTC monograph establishes conditions under which ingredients are generally recognized as safe and effective (GRASE). This rule would update the 1999 monograph.  The Proposed Rule also requests additional information to inform future decisions about the GRASE status of active ingredients, particularly nanoscale ingredients. The FDA will consider ingredients to be nano if they are of nanoscale (1-100nm) or if they exhibit properties characteristic of nanomaterials even if they are slightly larger (up to 1mm).

These new guidelines on nanoscale ingredients primarily refer to the current use of active ingredients zinc oxide and titanium dioxide in their nanomaterial form in OTC sunscreens. After reviewing the available scientific information, the FDA does not propose to distinguish the nanoscale forms of zinc oxide and titatium dioxide from bulk forms, meaning these nanoscale ingredients will not be regulated differently than their bulk counterparts.  The FDA says that it will apply the new rule to other FDA-regulated products in addition to sunscreens.  The FDA invites comments on other nanomaterials used in sunscreen and safety and efficacy of nanomaterials in sunscreens.

The Sunscreen Innovation Act of 2014 has called for the FDA to announce their final sunscreen monograph by November 26, 2019. The proposed rule is seeking additional comment from the public until June 28th, 2019 regarding scientific data and public concerns about the safety and efficacy of using nanomaterials in sunscreens and other products.