Otc - Active Ingredient
Active Ingredient
Zinc oxide 17.88%
Uv Defense Face Mineral Spf 50 Lotion
FDA Label NDC 87458-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Invention Ltd for the product Uv Defense Face Mineral Spf 50 (NDC 87458-003). 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, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- help 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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor 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
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thi 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. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
- children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
water, butyloctyl salicylate, propylheptyl caprylate, butylene glycol, isododecane, C9-12 alkane, cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone, caprylyl methicone, disiloxane, triethylhexanoin, glycerin, methyl methacrylate crosspolymer, disteardimonium hectorite, sodium chloride, triethoxycaprylylsilane, polymethylsilsesquioxane, 1,2-hexanediol, dipentaerythrityl tri-polyhydroxystearate, lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone, lauryl dimethicone/polyglycerin-3 crosspolymer, magnesium sulfate, tocopherol, caprylyl glycol, glyceryl caprylate, oryza sativa (rice) bran extract, sodium ascorbyl phosphate, dipropylene glycol, sodium hyaluronate, sodium citrate, panthenol, centella asiatica extract, pentylene glycol, octanediol.
Other Information
Other information
- protect the product in this container from excessive heat and direct sun.
Questions Or Comments?
Questions or comments?
Package Label.Principal Display Panel
Tube (Facemineralspf50 Pp)
Carton (Facemineralspf50 Sp)
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