Otc - Active Ingredient
Avobenzone 2.85%
Octinoxate 7.25%
Octisalate 4.50%
Octocrylene 9.50%
Prvwora Ultra Defense Sunscreen Cream
FDA Label NDC 87482-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cellarkbio Inc. for the product Prvwora Ultra Defense Sunscreen (NDC 87482-001). 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, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, other safety information, 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) decrease the risk of skin cancer and early skin aging caused by the sun
Dosage & Administration
For sunscreen use:
Apply liberally 15 minutes before sun exposure
Reapply at least every two 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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses
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.
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
Inactive Ingredient
Water, Silica, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Butylene Glycol, 1,2-Hexanediol, Sodium Stearoyl Glutamate, Polyglyceryl-6 Stearate, Dimethicone, Stearyl Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrolyzed Sclerotium Gum, Polyglyceryl-3 Methylglucose Distearate, Octadecene, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Microcrystalline Cellulose, Isohexadecane, Poly C10-30 Alkyl Acrylate, Ethylhexylglycerin, Polyacrylate Crosspolymer-6, Fragrance, Disodium EDTA, Xanthan Gum, Polysorbate 80, Polyglyceryl-6 Behenate, Cellulose Gum, Niacinamide, Tranexamic Acid, 4-Butylresorcinol, Gluconolactone, Mandelic Acid, D-Pentapeptide-1, Phytic Acid
Other Safety Information
Protect the product in the container from excessive heat and direct sun.
* Please review the disclaimer below.
