Otc - Active Ingredient
Active ingredients purpose
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Malin & Goetz Inc for the product Malin And Goetz (NDC 53634-152). 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
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Oxybenzone 2% Sunscreen
Uses
For skin highly sensitive for sunburn
helps prevent sunburn
higher SPF gives more sunburn protection
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 skin rash occurs
Warnings
For external use only
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothin and using a sunscreen
Directions
Apply liberally before sun exposure. Apply and reapply as directed to avoid lowering protection.
Reapply at least every 2 hours. Children under 6 months: Ask a doctor
Water (Aqua), Octyl Dodecyl Neopentanoate, Isocetyl stearate, glycerin, cetyl alcohol, glyceryl stearate, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (olive) Fruit oil, Butyrospermum Parkii (Shea butter), Ormenis Multicaulis, Tocopheryl Acetate, Butylene Glycol, Camellia Oleifera Leaf Extract, Magnesium Ascorbyl Phosphate, Cyano-cobalamin, Cholecalciferol, Retinyl Palmitate, C13-C16 Isoparaffin, C12-C14 Isoparaffin, C13-C15 Alkane, Titanium Dioxide, Polysorbate 80, Carbomer, Triethanolamine, phenoxyethanol, Sodium Dehydroacetate.
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