PROCEUTICALS PRIVATE LABEL BY TIZO TINTED MINERAL SUNSCREEN STICK- titanium dioxide, zinc oxide stick

Proceuticals Private Label by TiZO tinted mineral sunscreen stick by

Drug Labeling and Warnings

Proceuticals Private Label by TiZO tinted mineral sunscreen stick by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, Ltd, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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.

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.

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

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO TINTED MINERAL SUNSCREEN STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CERESIN (UNII: Q1LS2UJO3A)
TOCOPHEROL (UNII: R0ZB2556P8)
HEXYLDECANOL (UNII: 151Z7P1317)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
GINGER OIL (UNII: SAS9Z1SVUK)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-220-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	09/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/06/2024

Labeler - Fallien Cosmeceuticals, Ltd (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-220)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	manufacture(58892-220)