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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

SHISEIDO AMERICA INC.: Sunscreen and Skincare Products Recalled for Manufacturing Quality Issues

Agency Publication Date: January 12, 2018
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Summary

Approximately 248,661 units of bareMinerals and Shiseido sunscreen and skincare products are being recalled because the active ingredients were not manufactured according to Good Manufacturing Practice (GMP) and quality standards. Affected products include bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion and several Shiseido Future Solution LX products containing SPF 50+. These products were distributed nationwide in various sizes, ranging from 2 mL sample tubes to 50 mL full-size bottles. Consumers should identify if they have these specific products by checking the SKU and NDC numbers on the packaging.

Risk

The manufacturing process for the active ingredients did not meet required quality and safety standards, which means the products may not provide the expected level of sun protection or could contain unintended impurities. While no specific injuries have been reported, using sub-standard sun protection can lead to skin damage or increased risk of sunburn.

What You Should Do

  1. Identify your product by checking the SKU and NDC numbers on the bottle or tube. For bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (40 mL), look for SKU BE8047201 and NDC 98132-761-01.
  2. For Shiseido Future Solution LX Universal Defense SPF 50+, check for NDC 58411-256-60 and SKUs: 8C52541 (2mL), 8B41841 (15mL), or 1155840, 1155841, 1155842, 1155851, 0710341, 0710342 (50mL).
  3. For Shiseido Future Solution sets, check for SKU 95167 (Discovery Set), SKU 95393 (Luxurious Eye & Lip Collection), or SKU 95284 (Triple Points Bonus).
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of these products and to discuss any skin concerns.
  5. Return any unused product to the pharmacy or place of purchase for a refund.
  6. Contact Shiseido America Inc. for further instructions regarding the return or disposal of these specific items.
  7. Contact the FDA Consumer Complaint hotline for additional questions at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund available via healthcare provider/pharmacy or place of purchase.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (40 mL/1.35 fl. oz.)
Model:
NDC 98132-761-01
Lot Numbers:
SKU#: BE8047201
Product: Shiseido Future Solution LX Universal Defense SPF 50+ (2 mL)
Model:
NDC 58411-256-60
Lot Numbers:
SKU#: 8C52541
Product: Shiseido Future Solution LX Universal Defense SPF 50+ (15 mL)
Model:
NDC 58411-256-60
Lot Numbers:
SKU#: 8B41841
Product: Shiseido Future Solution LX Universal Defense SPF 50+ (50 mL)
Model:
NDC 58411-256-60
Lot Numbers:
SKU#: 1155840
SKU#: 1155841
SKU#: 1155842
SKU#: 1155851
SKU#: 0710341
SKU#: 0710342
Product: Shiseido Future Solution LX Discovery Set (15 mL)
Lot Numbers:
SKU#: 95167
Product: Shiseido Future Solution LX Luxurious Eye & Lip Collection (15 mL)
Lot Numbers:
SKU#: 95393
Product: Shiseido Future Solutions LX Triple Points Bonus (15 mL)
Model:
NDC 58411-256-60
Lot Numbers:
SKU#: 95284

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78791
Status: Resolved
Manufacturer: SHISEIDO AMERICA INC.
Sold By: Bare Escentuals Beauty, Inc.; Shiseido Americas Corporation
Manufactured In: United States
Units Affected: 248,661 bottle and /tubes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.