FDA recall D-1540-2020

Product

Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3

Reason for recall

Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.

Distribution

Shipped to one distributer located in Colorado

Key facts

Status

Terminated

Initiation date

2020-06-03

Report date

2020-09-02

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-1540-2020