Otc - Active Ingredient
ACTIVE INGREDIENTS:
Zinc Oxide 16%
Proceuticals Private Label By Tizo Non-tinted Replenishing Daily Protection Cream
FDA Label NDC 58892-226
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 Non-tinted Replenishing Daily Protection (NDC 58892-226). 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 skin aging caused by the sun.
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:
Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane,
Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer,
Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol,
Hydrogen Dimethicone, PEG-10 Dimethicone,
Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate, Vinyl Dimethicone/Methicone
Silsesquioxane Crosspolymer
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 caused by the sun.
Apply liberally 15 minutes befor sun exposure.
Package Label.Principal Display Panel
Principal Display Panel – 50g Bottle Label
PROCEUTICALS
PRIVATE LABEL by TiZO
non-tinted replenishing
daily protection
broad spectrum spf 40
with ceramides, zinc oxide
& antioxidants C & E
net wt. 1.75 oz / 50 g
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