Vertra Elemental Resistance Sun Protection Cream recalled over manufacturing violations

Recall date

November 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

EAI-JR286 INC recalls Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Prot…

Recall number

D-0100-2018

FDA classification

Class II

Brand / firm

EAI-JR286 INC

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.