Active Ingredients:
Titanium Dioxide 8%
Zinc Oxide 3.8%
Mineral Sunscreen Spf 40 Tinted Cream
FDA Label NDC 85296-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skin Restoration Aesthetics for the product Mineral Sunscreen Spf 40 Tinted (NDC 85296-203). 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:, directions:, inactive ingredients:, other information:, warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Sunscreen
Uses:
Helps prevents 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:
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medicalhelp or contact a Poison Control Center right away.
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
• Children under 6 months: Ask a doctor
• Sun Protection Measures: Spending time 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 am-2 pm
• Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate
Other Information:
• Protect this product from excessive heat and direct sun
• May stain some fabrics
• PA +++
Warning:
Keep out of the reach of children
* Please review the disclaimer below.
