Otc - Active Ingredient
Active Ingredients Purpose
Octinoxate 6%, Zinc Oxide 12% Sunscreen
Spf 50 Moisturizing Sunscreen Broad Spectrum
FDA Label NDC 72274-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gate Therapeutics for the product Spf 50 Moisturizing Sunscreen Broad Spectrum (NDC 72274-002). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If Product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
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.
Dosage & Administration
Directions
• Apply liberally 15 minutes before sun exposure
• Reapplyat least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10a.m. – 2p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under six months consult a physician
Inactive Ingredient
Inactive ingredients Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol
Package Label.Principal Display Panel
SPF 50+
Moisturizing Sunscreen
Broad Spectrum Daily Use
1Fl Oz/30 mL
Tube 1 Oz (1oz Tube Spf50)
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