TIZO TINTED MOISTURIZING SERUM - MEDIUM- zinc oxide cream

TiZO Tinted Moisturizing Serum - Medium by

Drug Labeling and Warnings

TiZO Tinted Moisturizing Serum - Medium by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, Ltd., Certified Laboratories, LLC, Mana Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Zinc Oxide 1%

Purpose:

Sunscreen

Uses:

Helps prevents 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.

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.

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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

C 12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, CetylPEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone,Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Magnesium Sulfate, Microcrystalline Wax, Octadecene, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Silica, Sodium Chloride, Sodium Hyaluronate, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Titanium Dioxide,
Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

Protect this product from excessive heat and direct sun. May stain some fabrics. Shake well before using.

Warnings:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO TINTED MOISTURIZING SERUM - MEDIUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CI 77491 (UNII: 1K09F3G675)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM SULFATE (UNII: DE08037SAB)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ISOHEXADECANE (UNII: 918X1OUF1E)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ISODODECANE (UNII: A8289P68Y2)
OCTADECENE (UNII: H5ZUQ6V4AK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE 3 (UNII: 4370DF050B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-133-50	1 in 1 CARTON	10/08/2024
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/08/2024

Labeler - Fallien Cosmeceuticals, Ltd. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Certified Laboratories, LLC		119002612	analysis(58892-133)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products, Inc.		078870292	manufacture(58892-133)