Active Ingredients Purpose
Zinc Oxide 20% Sunscreen
Dermatone Mineral Spf 30 Lotion
FDA Label NDC 54414-030
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 Mineral Spf 30 (NDC 54414-030). 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, indications & usage, warnings, inactive ingredeints, dosage & administration, 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
• 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.
When using this product:
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
Inactive Ingredeints
WATER
CAPRYLIC/CAPRIC TRIGLYCERIDE
COCO-CAPRYLATE
BUTYLOCTYL SALICYLATE
NIACINAMIDE
POLYHYDROXYSTEARIC ACID
GLYCERIN
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
SUCROSE PALMITATE
XANTHAN GUM
CITRIC ACID
SACCHARIDE ISOMERATE
SUCROSE TRISTEARATE
SODIUM STEAROYL GLUTAMATE
BENZYL ALCOHOL
DEHYDROACETIC ACID
SODIUM PHYTATE
Dosage & Administration
DIRECTIONS
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.
•
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.
* Please review the disclaimer below.
