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
Reported: May 18, 2016 Initiated: October 15, 2015 #D-0849-2016
Product Description
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
Reason for Recall
cGMP Deviations; product does not comply with cGMP requirements
Details
- Recalling Firm
- Sesderma, SL
- Units Affected
- 27 bottles
- Distribution
- Distributed to following states: FL, PR, CO, GA.
- Location
- Rafelbunol, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sesderma, SL. Units affected: 27 bottles.
Why was this product recalled? ▼
cGMP Deviations; product does not comply with cGMP requirements
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 18, 2016. Severity: Moderate. Recall number: D-0849-2016.
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