Active Ingredients
AVOBENZONE 3.0%
HOMOSALATE 7.0%
OCTISALATE 5.0%
OCTOCRYLENE 8.0%
Ultra Violette Supreme Screen Broad Spectrum Spf 50 Cream
FDA Label NDC 84803-100
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 Supreme Screen Broad Spectrum Spf 50 (NDC 84803-100). 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, use, for external use only, 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
Use
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
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 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, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, lsododecane, Copernicia Cerifera (Camauba) Wax, Oryza Saliva (Rice) Bran Wax, Polysorbate 60, Dimethicone, Ceteareth-20, Nylon- 6/12, Saccharide lsomerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Fragrance, Disodium EDTA,
Pentylene Glycol, Caprylhydroxamic Acid, Triethanolamine, Lactic Acid, Sorbitan lsostearate, Sodium Citrate, Iron Oxides (Cl 77491), Iron Oxides (Cl 77492), Iron Oxides (Cl 77499).
Other Information
protect this product from excessive heat and direct sun
Principal Display Panel
8480310050 (2408 Uv Supreme Screen Us 50ml Carton Ss50c1us Fa2 Ol)
Supreme Screen Broad Spectrum SPF 50
1.7 FL. OZ. (50 mL)
* Please review the disclaimer below.
