Active Ingredients Purpose
Avobenzone 3.00% Sunscreen
Homosalate 10.00% Sunscreen
Octisalate 5.00%. Sunscreen
Dermatone Spf50 Sunscreen Spray
FDA Label NDC 54414-028
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 Spf50 Sunscreen (NDC 54414-028). 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 active ingredients purpose, uses, warnings for external use only. flammable:, do not use, when using this product, stop use and ask doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
•helps prevent sunburn•
Warnings For External Use Only. Flammable:
Do not use near heat, flame or while smoking.
Do Not Use
on damaged or broken skin.
When Using This Product
• keep out of eyes. Rinse with water to remove. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Stop Use And Ask Doctor If
rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
• spray liberally and spread evenly by hand 15 minutes before sun exposure• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face
• do not apply in windy conditions • use in a well-ventilated area
• Sun Protection Measures. Spending tme in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from
10 a.m. - 2. p.m. • wear a long-sleeve shirt, pants, hats, and sunglasses.
• children under 6 months: Ask a doctor.
Inactive Ingredeints
Alcohol Denat.
Butyloctyl Salicylate
Fragrance
Oryza Sativa (Rice) Bran Oil
Polyester-8
VA/Butyl Maleate/Isobornyl Acrylate Copolymer
Mineral Oil
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
* Please review the disclaimer below.
