Otc - Active Ingredient
Zinc Oxide 17%
Universal Glow Daily Defense Spf 40
FDA Label NDC 71501-1903
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Loretta, Llc for the product Universal Glow Daily Defense Spf 40 (NDC 71501-1903). 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, inactive ingredients, warnings, dosage & administration, indications & usage, 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
Sunscreen
Inactive Ingredients
Aqua (Water/Eau), Isododecane, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, C12-15 Alkyl Benzoate, Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Lecithin, Phenoxyethanol, Tapioca Starch Polymethylsilsesquioxane, Propylene Carbonate, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Ectoin, Glycerin, Polyglyceryl-10 Laurate, Tromethamine, Ethylhexylglycerin, Octyldodecanol, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil, Decyl Glucoside, Dimethylmethoxy Chromanol, Sodium Benzoate, Betula Alba Bark Extract, Boswellia Serrata Extract, Polygonum Cuspidatum Root Extract, Caprylyl Glycol, Hexylene Glycol, Jojoba Esters, Trihydroxystearin, Alumina, Centella Asiatica Extract, Tocopherol, Silica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491).
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.
Stop and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally and evenly 15 minutes before sun exposure. Reapply at last every 2 hours. Use a water-resistant sunscreen if swimming or sweating.
Indications & Usage
Helps prevent suburn
Package Label.Principal Display Panel
Principle Display Panel (Ugdd)
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