FDA-Drug2016-05-18Class II

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

Sesderma, SL
Hazard

cGMP Deviations; product does not comply with cGMP requirements

Sold states
Distributed to following states: FL, PR, CO, GA.
Affected count
15 bottles
Manufactured in
Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A, Spain
Products
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0844-2016

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