Sesderma, SL recalls Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream,
Recalled May 18, 2016 · FDA recall D-0845-2016 · Sesderma, SL
Hazard
cGMP Deviations; product does not comply with cGMP requirements · FDA Class II
Units
20 bottles
Sold at
Distributed to following states: FL, PR, CO, GA.
Description
cGMP Deviations; product does not comply with cGMP requirements
Product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
Manufacturer(s)
Sesderma, SL
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →