FDA recall D-1486-2020

Product

Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA

Reason for recall

Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-06-13

Report date

2020-08-12

Termination date

2024-02-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clearfield, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1486-2020