Otc - Active Ingredient
ACTIVE INGREDIENTS:
Titanium Dioxide 10%
Zinc Oxide 3%
Proceuticals Private Label By Tizo Daily Defense Tinted Mineral Sunscreen Cream
FDA Label NDC 58892-258
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 Daily Defense Tinted Mineral Sunscreen (NDC 58892-258). 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 otc - active ingredient, otc - purpose, indications & usage, inactive ingredient, other safety information, warnings, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE:Sunscreen
Indications & Usage
DIRECTIONS:
• Apply liberally 15 minutes before sun exposure.
• Reapply:
• After 40 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 Ingredient
INACTIVE INGREDIENTS:
Bismuth Oxychloride, Capric/Caprylic Triglyceride,
Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20,
Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium
EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides,
Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint)
Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,
PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl
Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine,
Triethoxycaprylylsilane, Water
Other Safety Information
OTHER INFORMATION:
• Protect this product from excessive heat and direct sun
• May stain some fabrics
Warnings
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 medical help or contact a Poison Control
Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of
children.
Dosage & Administration
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.
Apply liberally 15 minutes before sun exposure.
Package Label.Principal Display Panel
Principal Display Panel – 53 g Bottle Label
Proceuticals
PRIVATE LABEL by TiZO
daily defense tinted
mineral sunscreen
broad spectrum spf 50
water resistant (40 minutes)
net wt. 1.8 oz / 53 g
Graphic-Untitled
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