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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

Yusef Manufacturing Laboratories, LLC: SPF30 Kiwi Flavored Lip Balm Recalled for High Octisalate Levels

Agency Publication Date: August 24, 2020
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Summary

Yusef Manufacturing Laboratories, LLC is recalling 2,558 tubes of Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm. The recall was initiated because the active ingredient, Octisalate, was found to be at a concentration 15% higher than the amount stated on the label. This superpotent formulation means users are applying more of the active drug than intended. Consumers should contact their healthcare provider or pharmacist regarding the use of this product and return any unused tubes to the place of purchase for a refund.

Risk

The product is superpotent, containing 15% more Octisalate than the labeled claim, which increases the concentration of active drug ingredients applied to the skin and may increase the risk of adverse reactions or skin irritation.

What You Should Do

  1. Identify your product by checking the label for 'Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm' in 0.15 Oz tubes with UPC 7 54018 20004 3.
  2. Verify if your tube is part of the recall by looking for Part ID 9PRKY01 and Batch or Lot number 13852.
  3. Contact your healthcare provider or pharmacist for guidance if you have experienced any adverse reactions while using this product.
  4. Return any unused product to the pharmacy or place of purchase for a full refund.
  5. Contact Yusef Manufacturing Laboratories, LLC or the distributor for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (0.15 Oz Tube)
Model:
9PRKY01
UPC Codes:
754018200043
Lot Numbers:
13852

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85814
Status: Resolved
Manufacturer: Yusef Manufacturing Laboratories, LLC
Sold By: Freeport West
Manufactured In: United States
Units Affected: 2,558 pieces
Distributed To: Colorado

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.