Otc - Active Ingredient
ACTIVE INGREDIENTS:Zinc Oxide 20%
Proceuticals Private Label By Tizo Tinted Mineral Sunscreen 20% Zinc Oxide Cream
FDA Label NDC 58892-204
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 Mineral Sunscreen 20% Zinc Oxide (NDC 58892-204). 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
USES: Helps prevent sunburn. If used as directed with other sun protection
measures (see Directions), decreases the risk of skin cancer and early aging
caused by the sun.
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, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl
Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane,
Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer,
Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium
EDTA, Glycerin, Iron Oxides, Hydrogren Dimethicone, Mica, Microcrystalline
Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4
Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride,
Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate,
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 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 cuased by the sun.
Apply liberally 15 minutes befor sun exposure.
Package Label.Principal Display Panel
Principal Display Panel – 113 g Bottle Label
PROCEUTICALS
PRIVATE LABEL by TiZO
non-tinted
mineral sunscreen
20% zinc oxide
broad spectrum spf 40
water resistant (40 minutes)
net wt. 4 oz/ 113 g
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