Otc - Active Ingredient
ZINC OXIDE 25%
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum Spf 40 Cream
FDA Label NDC 84803-115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grace And Fire Usa Inc. for the product Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum Spf 40 (NDC 84803-115). 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, indications & usage, warnings, for external use only, 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
Otc - Purpose
SUNSCREEN
Indications & Usage
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
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
Directions for Sunscreen Use
● apply liberally and evenly 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 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. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor
Inactive Ingredients
Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Caprylic/ Capric Triglyceride, Silica, Copernicia Cerfera (Carnauba) Wax, Microcrystalline Cellulose, Stearalkonium Hectorite, Glycerin, Triethoxycaprylylsilane, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Saccharide lsomerate, Polyhydroxystearic Acid, Hydroxyacetophenone, Sodium Chlorde, Phenoxyethanol, Propanediol, Panthenol, Tocopheryl Acetate, Pongamol, Oryza Sativa (Rice) Bran Wax, Citric Acid, Bisabolol,, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Nelumbo Nucifera (Lotus) Flower Wax, Sodium Citrate, Pantolactone, Tocopherol, Ganoderma Lucidum (Mushroom) Extract, Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77491),
Iron Oxides (C.I. 77499)
Other Information
Protect this product in this container from excessive heat and direct sun
Package Label.Principal Display Panel
ULTRA VIOLETTE
VELVET SCREEN BROAD SPECTRUM SPF 40
BLURRING MINERAL SKINSCREEN
1.7 FL. OZ../ 50 ml
Uv Velvet Screen (Uv Velvet Screen Spf40 Us 50ml Carton)
* Please review the disclaimer below.
