Otc - Active Ingredient
Active Ingredients:
Avobenzone 3%
Octocrylene 8%
2000dl-cl30v
FDA Label NDC 58418-005
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 2000dl-cl30v (NDC 58418-005). 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, indications & usage, warnings, keep out of reach of children., dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Sunscreen
Indications & Usage
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
WARNINGS: Skin Cancer/ Sking 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 keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash occurs.
Keep Out Of Reach Of Children.
Keep out of reach of children. If product is swallowed, get immediate medical help or contact a Poison Control Center
right away.
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun exposure
- Reapply:
*after 80minutes of swimming or sweating
* immediately after towel drying
*at least every 2 hours
*Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients: Water, Acrylates/C10-30, Alkyl Acrylate cross polymer, Stearic Acid, Glyceryl Monostearate, Bis-Octyldodecyl Dimer Dillinoleate/Propanediol Copolymer, Sorbeth-2-Hexaoleate, Phenoxylethanol, Ethylhexylglycerin, Triethanolamine, Disodium EDTA.
Other Safety Information
Other Information: Protect product from excessive heat and direct sun
Otc - Questions
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