Otc - Active Ingredient
ACTIVE INGREDIENTS:
Titanium Dioxide 4.0%
Zinc Oxide 5.5%
Proceuticals Private Label By Tizo Tinted Mineral Sunscreen Stick
FDA Label NDC 58892-220
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 Stick (NDC 58892-220). 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:DIRECTIONS: Apply liberally 15 minutes before
sun exposure. Reapply: • After 80 mintues of
swimming or sweating • Immediately after towel
drying • 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: Alumina, Aluminum
Hydroxide, Aluminum Stearate, Ascorbic Acid,
Ascorbyl Palmitate, C12-15 Alkyl Benzoate,
Cetearyl Isononanoate, Cetyl PEG/PPG-15/15
Butyl Ether Dimethicone, Citric Acid, Ethylene
Brassylate, Ethylhexyl Palmitate, Helianthus
Annuus (Sunflower) Wax, Hexyldecanol,
Hexyldecyl Laurate, Iron Oxide, Lecithin,
Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate,
Polyhydroxystearic Acid, Propylene Glycol
Dicaprylate/Dicaprate, Stearic Acid,
Tocopherol, Tocopheryl Acetate, Zingiber
Officinale (Ginger) Root Oil
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 befor sun exposure.
Package Label.Principal Display Panel
Principal Display Panel – 30g Cylinder Label
PROCEUTICALS
PRIVATE LABEL by TiZO
tinted mineral
sunscreen stick
broad spectrum spf 45
water resistant (80 minutes)
Net Wt. 1 oz. /30 g
Graphic-Untitled
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