Class II · Moderate risk Ongoing
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective…
Reason Out of Specification for active ingredient
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
What was recalled
Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
- Recalling firm
- Linde Eckstein Gmbh + Co KG
- Origin
- N/A, Germany
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1099-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Octocrylene recalls
See all
Class II · Moderate risk Ongoing
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad…
Reason Out of Specification for active ingredient
Class I · High risk Terminated
Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in…
Reason Chemical contamination: presence of benzene
Class I · High risk Terminated
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45…
Reason Chemical contamination; presence of benzene
Class II · Moderate risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%)…
Reason cGMP Deviations
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