FDA recall D-0977-2016

Bayer Health Care LLC · Class II · drug

Product

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

Reason for recall

Labeling; Product Contains Undeclared API (Oxybenzone)

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-05-10
Report date: 2016-06-15
Termination date: 2016-10-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cleveland, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0977-2016