The Recall Desk
ModerateFDA (Drugs)·D-0849-2016·Announced 2016-05-18

Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text cites cGMP deviations without reporting specific illnesses or injuries, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Sesderma, SL is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottles. The product is manufactured by Sesderma S.L. in Valencia, Spain, and is available over the counter. The recall is due to cGMP deviations, meaning the product does not comply with current Good Manufacturing Practice requirements.

The affected product includes Lot code 51064901 with an expiration date of 07/17 and Lot code 51064902 with an expiration date of 04/18. The recall number is D-0849-2016. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
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
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot code 51064901
  • exp 07/17
  • Lot code 51064902
  • exp 04/18

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 10 recalled by Sesderma, SL under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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