Otc - Active Ingredient
Active ingredients
Avobenzone 3.0%
Homosalate 10.0%
Octocrylene 6.0%
Dermatone Sport Spf 50 Lotion
FDA Label NDC 54414-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermatone Labs Llc for the product Dermatone Sport Spf 50 (NDC 54414-027). 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, indications & usage, warnings, otc - keep out of reach of children, inactive ingredient, dosage & administration, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Uses
• Helps prevent sunburn, higher SPF gives more sunburn protection
Warnings
WARNINGS
For external use only.
When using this product:
• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Inactive Ingredient
Aluminum Starch Octenylsuccinate
Benzyl Alcohol
Butyloctyl Salicylate
Carbomer
D-Glucitol
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Fragrance
Phenoxyethanol
Polyglyceryl-3-Distearate
Sorbitan Isostearate
Stearic Acid
Triethanolamine
VP/Eicosene Copolymer
Water
Dosage & Administration
DIRECTIONS
• Apply liberally 15 minutes before sun exposure.
• Reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
٠For sunscreen use
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.
Otc - Purpose
Sunscreen
* Please review the disclaimer below.
