The Recall Desk
ModerateFDA (Drugs)·D-0850-2016·Announced 2016-05-18

Sesderma Sunscreen Recalled for cGMP Deviations

Sesderma is recalling 45 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 text cites cGMP deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sesderma, SL is recalling 45 compacts of Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 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 H-04 and expiration date 07/2019. It was distributed to the states of 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 recalling firm for further instructions.

The recalled product

Product
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
Manufacturer
Sesderma, SL
Category
Drug — Sunscreen
Hazard
Affected units
45

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 H-04
  • exp 07/2019

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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