Otc - Active Ingredient
Active Ingredient Purpose
Octinoxate 7.5% Sunscreen
Avobenzone 2.0% Sunscreen
Oxybenzone 2.0% Sunscreen
Octocrylene 1.9% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Ole Henriksen for the product Truth Revealed Super Creme Spf 15 (NDC 51770-001). 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 Ingredient Purpose
Octinoxate 7.5% Sunscreen
Avobenzone 2.0% Sunscreen
Oxybenzone 2.0% Sunscreen
Octocrylene 1.9% Sunscreen
Uses:
Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Keep out of reach of children
Stop use and ask a doctor if rash or irritation develops and lasts
Warnings
For external use only
When using this product keep out of eyes. Rinse with water to remove.
If swallowed, get immediate medical help or contact a poison control center right away.
Directions
Massage into skin in upward motion, outward circular motions
For children under 6 months, ask a doctor.
Inactive Ingredients
Water (Aqua,Eau), cocoglycerides, Glycerin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Palmitoyl Tripeptide-5, Algae Extract, Pullulan, Chondrus Chrispus (Carrageenan), Plukenetia Volubilis Seed Oil, Schinus Terebinthifolius Seed Extract, Tetrahexyldecyl Ascorbate, calcium Ascorbate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Extract, Corylus Avellana (Hazelnut) extract, Avena Sativa (Oat) Meal Extract. Vaccinum Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharinum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Bisabolol, Allantoin, Tocopheryl Acetate, Carbomer, Ceteareth-20, Aminomethyl Propanol, sodium Phytate, Citric Acid, Polyacrylate-13/polyisobutene/polysorbate 20, Phenoxy ethanol, Ethylhexylglycerin, Potassium Sorbate, Fragrance (Parfum)
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