Otc - Active Ingredient
Active ingredients
Avobenzone 3.0%
Homosalate 15.0%
Octisalate 5.0%
Octocrylene 10.0%
Dermatone Spf 30 Lotion
FDA Label NDC 54414-048
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 Spf 30 (NDC 54414-048). 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, use in specific populations, warnings, otc - when using, 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
Use In Specific Populations
Uses
• Helps prevent sunburn, higher SPF gives more sunburn protection
• retains SPF after XX minutes of activity in the water or sweating
• provides moderate protection against 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
For external use only.
Highly Flammable: Do not apply or use product near heat, flame, or while smoking.
When using this product:
• keep out of eyes. Rinse with water to remove.
• Keep away from face to avoid breathing it.
• Do not puncture or incinerate, Contents under pressure
• Do not store at temperature above 120⁰F
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Otc - When Using
When using this product:
• keep out of eyes. Rinse with water to remove.
• Keep away from face to avoid breathing it.
• Do not puncture or incinerate, Contents under pressure
• Do not store at temperature above 120⁰F
Stop use and ask a doctor if rash occurs.
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
Behenyl Alcohol
BHT
Butyloctyl Salocylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Glyceryl Stearate
Hydrated Silicia
PEG-100 Stearate
Phenoxyethanol
Polyester-8
Sodium Polyacrylate
Styrene/ Acrylate Copolymer
Trideceth-6
Trimethylsiloxysilicate
VP/Hexadecene Copolyer
Water
Xanthan Gum
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
٠Hold container 4 to 6 inches from the skin to apply.
٠Do not spray directly into face. Spray on hands then apply to face.
٠Do not apply in windy conditions.
٠Use in a well-ventilated area.
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
Package Label.Principal Display Panel
Dermatone Spf 30 (Dermatone Sport Spf30 Lotion)
* Please review the disclaimer below.
