FDA-Drug2016-05-18Class II
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
Sesderma, SL
Hazard
cGMP Deviations; product does not comply with cGMP requirements
Sold states
Distributed to following states: FL, PR, CO, GA.
Affected count
20 bottles
Manufactured in
Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A, Spain
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0845-2016Don't want to check this manually?
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