Active Ingredients
Titanium Dioxide 1.75%, Zinc Oxide 3%
Unsun
FDA Label NDC 58443-0305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises Inc. for the product Unsun (NDC 58443-0305). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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 Use 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.
Directions
Apply liberally 15 minutes before sun exposure
Reapply
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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. to 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor.
Inactive Ingredients
Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Glycerin, Hexyl Laurate, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane,Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Water
Other Information
protect this product from excessive heat and direct sun.
Questions Or Comments?
Unsun Spf 15 Mineral Body Lotion
Principal Display Label (58443 0305 3)
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