Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Oxybenzone 6.0% Sunscreen
Facescreen
FDA Label NDC 49825-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioelements for the product Facescreen (NDC 49825-122). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings
For external use only
Do not use on broken or damaged skin
When using this product Keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
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 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
Inactive Ingredient
Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomile Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua,Eau)
Image Of Carton Art (Carton)
Package Label.Principal Display Panel
Bioelements
SPF 50 FaceScreen
Broad Spectrum SPF 50 Sunscreen
68 mL/ 2.3 Fl. Oz.
Image Of Jar Art (Jar)
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