Dosage And Administration
Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, AND at least every 2 hours.
Ss-tmpfl
FDA Label NDC 58418-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tropical Enterprises International, Inc. for the product Ss-tmpfl (NDC 58418-001). 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 dosage and administration, 80mn update, inactive ingredient, other safety information, otc - keep out of reach of children, otc - purpose, warnings, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
80Mn Update
Apply liberally and evenly 15 minutes before sun exposure.
Reapply after 80 minutes of swimming or sweating, immediately after
towel drying AND at least every 2 hours.
Inactive Ingredient
Inactive Ingredients: Alcohol Denatured, Sorbeth-2 Hexaoleate, Acrylates/, Octylacrylamide Copolymer
Other Safety Information
Other Information:
Protect product from excessive heat and direct sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed seek immediate medical attention or contact a Poison Control Center right away.
Otc - Purpose
Purpose: Sunscreen
Warnings
WARNINGS: Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer and early skin aging.
For external use only.
When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.
Stop use and ask a doctor if irritation or rash develops and persists.
Otc - Active Ingredient
Active Ingredients
Avobenzone 3%
Octocrylene 8%
Otc - Questions
Questions? Call
* Please review the disclaimer below.
