PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED FOAMING MINERAL SUNSCREEN- titanium dioxide, zinc oxide aerosol, foam

Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen by

Drug Labeling and Warnings

Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, Ltd, Tri-Pac Inc, Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Titanium Dioxide 3%

Zinc Oxide 10%

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:
Shake well before using.
Press nozzle carefully during first use
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:Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl
Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium
EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Isododecane, Isohexadecane,
Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl
Erucate, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate
80, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane,
Water

OTHER SAFETY INFORMATION

OTHER INFORMATION:
Protect this product from excessive heat and direct sun.
Store between 68° to 104° F (20° to 40° C).
Do not store at temperatures above 120° F.

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 – 100g Can Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted foaming

mineral sunscreen

broad spectrum spf 30

water resistant (40 minutes)

net wt. 3.5 oz/ 100 g

Graphic-Untitled

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED FOAMING MINERAL SUNSCREEN 
titanium dioxide, zinc oxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERETH-26 (UNII: NNE56F2N14)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISODODECANE (UNII: A8289P68Y2)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-211-01	100 g in 1 CAN; Type 0: Not a Combination Product	08/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/09/2024

Labeler - Fallien Cosmeceuticals, Ltd (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Tri-Pac Inc		020844956	manufacture(58892-211)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-211)