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DRUG FACTS
Product of Hungary
www.omorovicza.com
Omorovicza Kft, 2 Andrassy Ut, 1061 Budapest
Mineral Uv Shield Spf30
FDA Label NDC 41442-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Omorovicza Kozmetikai Kft. for the product Mineral Uv Shield Spf30 (NDC 41442-152). 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 other, otc - purpose, uses, warning, otc - stop use, otc - keep out of reach of children, otc - when using, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| ACTIVE INGREDIENTS | PURPOSE |
|---|---|
| Titanium Dioxide 1.5% | Sunscreen |
| Zinc Oxide 8.6% | Sunscreen |
Uses
Protects from UVA/B sunrays
Warning
For external use only; do not swallow.
Otc - Stop Use
Stop use if rash or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach for children.
Otc - When Using
When using this product keep out of eyes.
Directions
Apply evenly to face and neck. Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating or immediately after towel drying or at least every 2 hours.
Ingredients
Aqua (Hungarian Thermal Water), Caprylic/Capric Triglyceride, Zinc Oxide, Silica, Squalane, Glycerin, Ethylhexyldodecanol, Stearyl Heptanoate, Cetearyl Olivate, Cetearyl Ethylhexanoate, Titanium Dioxide, Sorbitan Olivate, Phenoxyethanol, Ascorbyl Tetraisopalmitate, Cetearyl Alcohol, Saccharomyces (Hungarian Thermal Water) Ferment Extract, Polyhydroxystearic Acid, Disodium EDTA, Alumina, Sodium Hyaluronate, Parfum (Fragrance), Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Ethylhexylglycerin, Isostearic Acid, Lactic Acid, Xanthan Gum, Phospholipids, Linalool, Limonene, Citral.
Principal Display Panel - 100 Ml Tube Box
MINERAL UV SHIELD
SPF 30
Omorovicza
BUDAPEST
e 3.4 fl oz 100ml
Principal Display Panel (100 ml Tube Box)
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