Otc - Active Ingredient
Active Ingredient
Zinc Oxide
Titanium Dioxide
Hawaiian Blend Sensitive Zinc Spf 50 Aerosol
FDA Label NDC 87313-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Islander Group for the product Hawaiian Blend Sensitive Zinc Spf 50 (NDC 87313-005). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Zinc Oxide - 19.5% ................. Sunscreen
Titanium Dioxide – 4.0%.................. Sunscreen
Warnings
WARNINGS
For external use only
Do not use on damaged or broken skin
when using this product keep out of eyes-rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutews befor sun exposure
Reaaply:
- after 80 monutes of swimming or sweating
- immediatly after towel drying
- at least every 2 hours
Indications & Usage
Helps prevent sunburn
Higher SPF gives more sunburn protection
If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s
Inactive Ingredient
Caprylic/Capric Triglyceride
Caprylyl Glycol
Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone
Dimethicone
Dimethicone/Methicone Copolymer
Sodium Phytate
Ethylhexylglycerin
Glycerin
Hydrogenated Polydecene
Isopropyl Myristate
Jojoba Esters
Pentylene Glycol
Polyhydroxystearic Acid
Propanediol
Silica
Sodium Chloride
Sorbitan Olivate
Stearic Acid
Synthetic Beeswax
Tetrafluoropropene
Fragrance
Water
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