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
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; product does not comply with cGMP requirements
What was recalled
Repaskin 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
- Recalling firm
- Sesderma, SL
- NDC code
- 63181-0013-1
- Origin
- N/A, Spain
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0844-2016
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
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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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