Repaskin 30 Facial Sunscreen gel cream recalled over manufacturing violations

Recall date

October 15, 2015

Source

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

Official notice title

Sesderma, SL recalls Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Bro…

Recall number

D-0849-2016

FDA classification

Class II

Brand / firm

Sesderma, SL

Sold / distributed

Distributed to following states: FL, PR, CO, GA.

Why it was recalled

cGMP Deviations; product does not comply with cGMP requirements

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

What was recalled

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1