TIZO TINTED MOISTURIZING SERUM - DEEP- zinc oxide cream

TiZO Tinted Moisturizing Serum - Deep by

Drug Labeling and Warnings

TiZO Tinted Moisturizing Serum - Deep 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 Ingredients:

Zinc Oxide 15%

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 the 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.

Warning:

Keep out of the freach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO TINTED MOISTURIZING SERUM - DEEP 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-135
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
CERAMIDE 3 (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
OCTADECENE (UNII: H5ZUQ6V4AK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
MAGNESIUM SULFATE (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-135-50	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(58892-135)

Establishment
Name	Address	ID/FEI	Business Operations
Mana Products, Inc.		078870292	manufacture(58892-135)