FDA Label for 2000dl-cl30v
View Indications, Usage & Precautions
2000dl-cl30v Product Label
The following document was submitted to the FDA by the labeler of this product Tropical Enterprises International, 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.
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.
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.
Recent Major Changes
Label change approved: 04-2020
Label change labeling: 04-2020
Uses section:
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 - Purpose
Purpose:
Sunscreen
Otc - Active Ingredient
Active Ingredients:
Avobenzone 3%
Octocrylene 8%
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. If product is swallowed, get immediate medical help or contact a Poison Control Center
right away.
Other Safety Information
*Protect product from excessive heat and direct sun
Otc - Questions
Questions or comments? Call toll free 1-800-535-5053
* Please review the disclaimer below.