FDA recall D-1176-2023

HUMANRACE · Class II · drug

Product

Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002

Reason for recall

Subpotent Drug: Product does not contain SPF that is declared on the label.

Distribution

Nationwide in the USA, Spain, Italy, UK, and France.

Key facts

Status
Ongoing
Initiation date
2023-08-18
Report date
2023-09-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Beverly Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1176-2023