PlainRecalls
FDA Drug Moderate Class II Terminated

Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

Reported: December 6, 2017 Initiated: November 28, 2017 #D-0100-2018

Product Description

Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

Reason for Recall

CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.

Details

Recalling Firm
EAI-JR286 INC
Units Affected
5,355 tubes
Distribution
Nationwide in the USA and Puerto Rico.
Location
Torrance, CA

Frequently Asked Questions

What product was recalled?
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.. Recalled by EAI-JR286 INC. Units affected: 5,355 tubes.
Why was this product recalled?
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 6, 2017. Severity: Moderate. Recall number: D-0100-2018.