FDA-Drug2016-05-18Class II
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
Sesderma, SL
Hazard
cGMP Deviations; product does not comply with cGMP requirements
Sold states
Distributed to following states: FL, PR, CO, GA.
Affected count
27 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%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0849-2016Don'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