FDA recall D-0590-2018

Bayer HealthCare Pharmaceuticals, Inc. · Class II · drug

Product

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.

Reason for recall

Labeling: Label mix-up

Distribution

Arkansas only

Key facts

Status
Terminated
Initiation date
2018-02-23
Report date
2018-03-14
Termination date
2020-01-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Whippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0590-2018