Active Ingredients:
Titanium Dioxide 8%
Zinc Oxide 3.8%
Proceuticals Private Label By Tizo Tinted Facial Mineral Sunscreen Backbar Cream
FDA Label NDC 58892-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd for the product Proceuticals Private Label By Tizo Tinted Facial Mineral Sunscreen Backbar (NDC 58892-201). 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:, warnings:, purpose:, directions:, inactive ingredients:, uses:, package label:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings:
Stop use and ask a doctor if rash occurs.
Do not use on broken or damaged skin.
Keep out of the reach of children.
Whe using this product, keep out of eyes.
For external use only. Do not use on damage 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 medical help or contact Poison Control Center right away.
Purpose:
Sunscreen
Directions:
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.
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
Uses:
Helps prevent 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.
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