Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.0% Sunscreen
Octisalate 5.0% Sunscreen
Oxybenzone 6.0% Sunscreen
Broad Spectrum Spf 50 Sunscreen
FDA Label NDC 49825-133
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 Broad Spectrum Spf 50 Sunscreen (NDC 49825-133). 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 damaged or broken 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 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, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (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)
Package Label.Principal Display Panel
Secondary (Secondary2)
Bioelements
Used in Professional Facials
SPF 50 FaceScreen
Broad Spectrum
SPF 50 Sunscreen
Daily antioxidant moisturizer
Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed
68 mL/ 2.3 Fl. Oz.
* Please review the disclaimer below.
