FDA Label for Total Sun Protection
View Indications, Usage & Precautions
Total Sun Protection Product Label
The following document was submitted to the FDA by the labeler of this product Cosmed Dermaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Octinoxate 7.5% w/w
Octisalate 3.0% w/w
Oxybenzone 3.0% w/w
Zinc Oxide 4.0% w/w
Purpose
Sunscreen
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
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 doctor if rash occurs. Keep out of reach of children. If product is swalled, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• Apply liberally 15 minutes before sun exposure and as needed
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 10am to 2pm
• Wear long sleeve shirts, pants, hats, and sun glasses
• Children under 6 months: Ask a doctor
Other Information
Protect this product from excessive heat and direct sun
Questions Or Comments:
Call 770-965-1022
Inactive Ingredients
Water, PPG-3 Myristyl Ether, Aloe Barbadensis Leaf Extract, Glycol Stearate, Cetyl Alcohol, Polyacrylamide, PVP/Hexadecene Copolymer, White Tea (Camellia Oleisera) Leaf Extract, Green Tea (Camellia Sinensis) Leaf Extract, Tocopheryl Acetate, Propylene Glycol, C13-14 Isoparaffin, Decyl Glucoside, Silica, Cetyl Phosphate, Glyceryl Stearate, PEG 100 Stearate, Glycerin, Diazolidinyl Urea, Triethoxycaprylylsilane, Methylparaben, Disodium EDTA, Propylparaben, Laureth-7
Package Label.Principal Display Panel
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