FDA-Drug2016-05-18Class II

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

Sesderma, SL
Hazard

cGMP Deviations; product does not comply with cGMP requirements

Sold states
Distributed to following states: FL, PR, CO, GA.
Affected count
66 bottles
Manufactured in
Calle Massamagrell 3-5, Poligono Industrial Rafelbunol, Rafelbunol, N/A, Spain
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0848-2016

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief