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GRASE rule proposed by FDA

SUNJIN NEWSLETTER

GRASE rule proposed by FDA

By Kim, Sanguk
February 2021, NO.3

Hi, How are you?

Have you heard about GRASE rule? GRASE is abbreviation of Generally Recognized As Safe and Effective(GRASE).

As sunscreen is classified as an over-the-counter (OTC) drug in the US, FDA identified sunscreens as shown in the table below.


So far, Zinc Oxide and Titanium Dioxide are the only sunscreen ingredients that the FDA deemed GRASE. Most of the other ingredients were withheld to be determined GRASE and additional safety data were required.

This rule is expected to accelerate Chemical Sunscreen Free trend.

 More details can be found in the following link. Please visit the site if you are interested.

<Related news>

– FDA advances new proposed regulation to make sure that sunscreens are safe and effective_FDA 2019.02.21

https://www.fda.gov/news-events/press-announcements/fda-advances-new-proposed-regulation-make-sure-sunscreens-are-safe-and-effective