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Unrated Drug recall · FDA · Published October 15, 2015

Sesderma Screenses Sunscreen Recall: cGMP Deviations

Sesderma recalls Screenses Color Sunscreen compacts due to cGMP deviations. Check lot H04.2 and expiration date 11/2019.

🇺🇸 FDA recall #D-0851-2016DrugSesderma ›
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Recalling firmSesderma, SLCalle Massamagrell 3-5, Poligono Industrial Rafelbunol · Rafelbunol, Spain
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sesderma, SL has recalled Screenses Color Sunscreen, a tinted facial make-up compact with Broad Spectrum SPF 50 in the Light shade. The recall is necessary because the product does not comply with current Good Manufacturing Practice (cGMP) requirements. Only 44 compacts were distributed to Florida, Puerto Rico, Colorado, and Georgia. Read more at govinfonow.com/recall/43568-sesderma-sl-recalls-screenses-color-sunscreen-tinted-facial-make-up.

Source Summary by GovInfoNow · govinfonow.com/recall/43568-sesderma-sl-recalls-screenses-color-sunscreen-tinted-facial-make-up · Updated October 11, 2026 · FDA enforcement record: FDA #D-0851-2016

Cite this page

“Sesderma Screenses Sunscreen Recall: cGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43568-sesderma-sl-recalls-screenses-color-sunscreen-tinted-facial-make-up. Based on FDA recall #D-0851-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0851-2016%22&limit=1).

Why it’s dangerous

The product failed to meet cGMP requirements, which are standards designed to ensure consistent quality and safety in pharmaceutical and cosmetic manufacturing. The record does not specify what specific defects occurred or what health risks these deviations might pose to users.

Who’s affected

Consumers who purchased Screenses Color Sunscreen tinted facial make-up compacts in Florida, Puerto Rico, Colorado, or Georgia are affected. Individuals using this specific cosmetic product are the ones at potential risk due to manufacturing non-compliance.

How to tell if you have this one

Check if you have a Screenses Color Sunscreen compact with the UPC 8 429979 252159. Verify the lot code is H04.2 and the expiration date is 11/2019. The product was distributed in FL, PR, CO, and GA.

  • Brand
    Sesderma
  • Product
    Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by
  • Category
    Drug
FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Distributed to following states: FL, PR, CO, GA.
Recall numberProduct, codes & lotsQuantity
D-0842-2016Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268; Lot code 40444601, exp 01/2019; Lot code 41414601, exp 05/2019; Lot code 40024602, exp 12/2018542 bottles
D-0843-2016Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016; Lot code 51004101, exp 2/2020, lot 43394101, exp 11/2019, lot 33444101, exp 11/2018459 bottles
D-0844-2016Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707; Lot code 41464901, exp 05/1715 bottles
D-0845-2016Repaskin 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; Lot code 41274901, exp 2/19.20 bottles
D-0846-2016Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221; Lot code 40414701, exp 09/19; Lot code 33524701, exp 10/18; Lot code 40144101, exp 10/18354 bottles
D-0847-2016Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1; Lot code 33454701, exp 11/18, lot 40424701, exp 1/2019195 bottles
D-0848-2016Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1; Lot code 51594901, exp 06/18,66 bottles
D-0849-2016Repaskin 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; Lot code 51064901, exp 07/17; Lot code 51064902, exp 04/1827 bottles
D-0850-2016Screenses 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; Lot code H-04, exp 07/201945 compacts
D-0851-2016Screenses 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; Lot code H04.2, exp 11/201944 compacts
Based on the official FDA remedy

What to do — step by step

  1. Check your product details

    Verify if your compact matches the UPC 8 429979 252159, lot code H04.2, and expiration date 11/2019.

Where it went and when

Where it was distributed

Distributed in 3 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Distributed to following states: FL, PR, CO, GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Florida, Georgia, Puerto Rico.

Recall timeline

FDA published this recall 7 months after the firm started it.

1. Firm started the recall: Oct 15, 201512. FDA classified it Class II: May 10, 201623. Published in FDA’s Enforcement Report: May 18, 2016320152016
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0851-2016 (October 15, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0851-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA