FDA Drug Class II — Moderate

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.

Hazard

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

Products

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 Ve
Brand
EAI-JR286 INC
UPC
Lot #: 609124, Exp 03/18 Manufacturing batches were mfg at Delta Laboratories under Batch Number 511103 11/16/2015 Batch Number 609124 09/21/2016

Units Affected

5,355 tubes