Repaskin 50 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 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tu…

Recall number

D-0848-2016

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 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1