FDA recall D-0341-2019

Product

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

Reason for recall

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

Distribution

United States, Maldives, Canada, United Arab Emirates, and New Zealand

Key facts

Status

Terminated

Initiation date

2018-12-10

Report date

2018-12-26

Termination date

2020-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2019