Total Sun Protection Lotion
FDA Label NDC 61352-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmed Dermaceuticals, Inc. for the product Total Sun Protection (NDC 61352-004). 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, uses, warnings, otc - keep out of reach of children, directions, other information, questions or comments:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Total Sun Protection (Label)

Total Sun Protection (Label)

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