TIZO MINERAL SUN DEFENSE SPF 50- titanium dioxide, zinc oxide cream

TiZO Mineral Sun Defense SPF 50 by

Drug Labeling and Warnings

TiZO Mineral Sun Defense SPF 50 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals Ltd., Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 10%, Zinc Oxide 3%

Purpose:

Sunscreen

Directions:

Apply liberally 15 minutes before sun exposure.

Warning:

For external use only.

Warning and Directions:

For external use only. Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

Warning:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO MINERAL SUN DEFENSE SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-128
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETEARETH-20 (UNII: YRC528SWUY)
IRON OXIDES (UNII: 1K09F3G675)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOHEXADECANE (UNII: 918X1OUF1E)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-128-05	5 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2023

Labeler - Fallien Cosmeceuticals Ltd. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-128)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-128)