PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED MINERAL SUNSCREEN 20% ZINC OXIDE- zinc oxide cream

Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide by

Drug Labeling and Warnings

Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide 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:Zinc Oxide 20%

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.

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: C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, 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 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 cuased by the sun.

Apply liberally 15 minutes befor sun exposure.

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 113 g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

20% zinc oxide

broad spectrum spf 40

water resistant (40 minutes)

net wt. 4 oz/ 113 g

Graphic-Untitled

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED MINERAL SUNSCREEN 20% ZINC OXIDE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
DIMETHICONE 100 (UNII: RO266O364U)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/25/2024

Labeler - Fallien Cosmeceuticals, Ltd (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	manufacture(58892-205) , pack(58892-205)