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Class II: temporary or reversible health riskTerminated

Yusef Manufacturing Laboratories Rocky Mountain Sunscreen SPF30 Kiwi Flavored Recall

Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Oc…

Yusef Manufacturing Laboratories, LLC · Clearfield, UT

Risk level
Class II
Reported by FDA
Sep 2, 2020
Recall ID
D-1540-2020
Check your lot numberHow we source this data

Summary

Yusef Manufacturing Laboratories recalled Rocky Mountain Sunscreen SPF30 Kiwi Flavored starting Jun 3, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1540-2020 on Sep 2, 2020. Reason: Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. Status: Terminated.

Why it was recalled

Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.

Product description

Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3

Lot numbers, UPCs & expiration codes

Part ID 9PRKY01, Batch #13852

Where it was sold

Shipped to one distributer located in Colorado

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1540-2020
Classification
Class II
Status
Terminated
Recall initiated
Jun 3, 2020
FDA report date
Sep 2, 2020
Quantity
2,558 pieces
Recall type
Voluntary: Firm initiated
Recalling firm
Yusef Manufacturing Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-1540-2020, exactly as published.

Show all FDA fields
City
Clearfield
State
UT
Status
Terminated
Country
United States
Event ID
85814
Address
Freeport West, F-4, #3
Code information
Part ID 9PRKY01, Batch #13852
Postal code
84016
Report date
Sep 2, 2020
Product type
Drugs
Recall number
D-1540-2020
Classification
Class II
Recalling firm
Yusef Manufacturing Laboratories, LLC
Product quantity
2,558 pieces
Termination date
Feb 13, 2024
Reason for recall
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Distribution pattern
Shipped to one distributer located in Colorado
Recall initiation date
Jun 3, 2020
Initial firm notification
E-Mail
Center classification date
Aug 24, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1540-2020, published Sep 2, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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