The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0845-2016·Announced 2016-05-18

Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

Sesderma is recalling 20 bottles of Repaskin 30 sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to cGMP deviations, which typically indicates a remote risk of temporary or medically reversible adverse health consequences, aligning with the Moderate severity criteria for minor compliance issues without reported illness.

Plain-English summary

Sesderma, SL is recalling 20 bottles of Repaskin 30 Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tubes. The product is identified by Lot code 41274901 and expiration date 2/19. It is manufactured by Sesderma S.L. in Valencia, Spain.

The recall was initiated because the product does not comply with current Good Manufacturing Practice (cGMP) requirements. The agency has classified this recall as Class II.

The affected product was distributed to Florida, Puerto Rico, Colorado, and Georgia. Consumers with this specific lot should stop using the product and contact the manufacturer for instructions.

The recalled product

Product
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
20

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 (2)

  • Lot code 41274901
  • exp 2/19.

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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