The Recall Desk
ModerateFDA (Drugs)·D-0851-2016·Announced 2016-05-18

Sesderma Sunscreen Recalled for cGMP Non-Compliance

Sesderma is recalling 44 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

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 involves a temporary or medically reversible adverse health consequence. The source cites cGMP deviations without reporting specific injuries or illnesses, fitting the Moderate severity criteria for voluntary precautionary or minor compliance issues.

Plain-English summary

Sesderma, SL is recalling 44 compacts of Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g). The recall is due to cGMP deviations, meaning the product does not comply with current Good Manufacturing Practice requirements.

The affected product is identified by Lot code H04.2 and expiration date 11/2019. It was distributed to Florida, Puerto Rico, Colorado, and Georgia.

Consumers should stop using the product and return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
44

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 H04.2
  • exp 11/2019

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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