Otc - Active Ingredient
ACTIVE INGREDIENT: Zinc Oxide 9%
Proceuticals Private Label By Tizo Eye Repair Non-tinted Mineral Sunscreen Cream
FDA Label NDC 58892-236
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 Eye Repair Non-tinted Mineral Sunscreen (NDC 58892-236). 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
• Use a water resistant product if swimming or sweating.
• Reapply 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: Butylene Glycol, Caffeine,
Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina
Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane,
Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone
Crosspolymer, Dimethiconol, Glycerin, Hydrogen
Dimethicone, Isododecane, Isohexadecane, Lauryl
PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl
Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20,
Saccharomyces/Selenium Ferment, Sambucus Nigra Flower
Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate, Undaria Pinnatifida Extract, Water
Other Safety Information
OTHER INFORMATION: • Protect this product from excessive
heat and direct sun
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 caused by the sun.
Apply liberally 15 minutes before sun exposure.
Package Label.Principal Display Panel
Principal Display Panel – 15 g Bottle Label
Proceuticals
PRIVATE LABEL by TiZO
eye repair non-tinted
mineral sunscreen
broad spectrum spf 20 with
gentle zinc oxide, peptides
& botanical blend
net wt. 0.5 oz. / 15 g
Graphic-Untitled
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