Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 2.6% Sunscreen
Octocrylene 2.4% Sunscreen
Oxybenzone 5.0% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Temmentec Ag for the product Sun Protection Emulsion Face Broad Spectrum Spf 30 (NDC 68807-307). 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.
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octisalate 2.6% Sunscreen
Octocrylene 2.4% Sunscreen
Oxybenzone 5.0% Sunscreen
Uses
helps prevent sunburn
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs.
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.
Directions
- apply daily after cleansing and toning
- smooth over face & throat
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- reapply at 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 of 15 or higher and other
sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredients
Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyalu-ronate, Corallina Officinalis Extract, Sea Water (Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dime- thoxydimethylindanone, Sodium Hydroxide, Porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Palmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propylparaben.
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