OTC Sunscreens Recalled

Humanrace is recalling more than a dozen lots of sunscreen because of subpotency. According to the September 27, 2023, US Food and Drug Administration (FDA) Enforcement Report, the products do not contain the sun protection factor (SPF) listed on the label.

The recall affects the following sunscreens, which were distributed throughout the US, Spain, Italy, the UK, and France:

• Humanrace Suncare Ozone Face Protection Daily Moisturizer, broad spectrum sunscreen, SPF 30, packaged in 53-mL bottles (NDC 82779-01), from lots 1732A, 1732B, 1742A, 1742B, 1742C, and 1742D (Exp. 6/24); and
• Humanrace Suncare Ozone Body Protection Cream, broad spectrum sunscreen, SPF 30, packaged in 148-mL bottles (NDC 82779-002), from lots 1752A, 1752B, 1782E, 1782G, 1782C, 1752C, and 1782B (Exp. 6/24).

Humanrace voluntarily initiated the recall August 18, 2023. The FDA designated the recall Class II on September 21, 2023. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

The products are sold over the counter to help prevent sunburn.