The following Structured Product Label (SPL) was submitted to the FDA by Amway Corp. for the product Peter Island Sunscreen (NDC 50390-705). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, warnings:, otc - stop use, otc - ask doctor, otc - keep out of reach of children, directions, other information, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients
Homosalate 10.0%Octisalate 5.0%Avobenzone 2.0%Octocrylene 2.0%Oxybenzone 2.0%
Warnings:
FOR EXTERNAL USE ONLY.Avoid contact with eyes. Rinse with water if contact occurs.
Otc - Stop Use
Discontinue use if signs of rash or irritation develop.
Otc - Ask Doctor
For use on children under the age of 6 months consult a physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Apply generously and evenly 30 minutes before sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.
- May stain some fabrics
- Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Other
This formula provides Broad Spectrum UVA/UVB protection from the sun's damaging rays. It is PABA free, vitamin enriched and very water resistant.
Principal Display Panel
PETER ISLANDSunscreen lotionspf 30PhotostableBroad SpectrumUVA/UVB ProtectionVery Water Resistant8 FL.OZ. (237 mL)
Inactive Ingredients
Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.
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