Broad Spectrum Spf45 Gel
FDA Label NDC 83286-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Drmtlgy, Llc for the product Broad Spectrum Spf45 (NDC 83286-014). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide 12%
Octinoxate 7.5%
Purpose
Sunscreen
Uses
Helps prevent sunburn. • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.
Precautions
• 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.
Inactive Ingredients:
Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane
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Packaging
Broad Spectrum Spf45 (83286014 2)
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