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., Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

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.

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. 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 Ingredients:

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

Other Information:

• Protect this product from excessive heat and direct sun
• May stain some fabrics

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

Principal Display Panel – 50 g Carton Label

TiZO®

MINERAL
SUN DEFENSE

Tinted

SPF
50

DAILY
MINERAL SUNSCREEN

Photoaging Defense

Titanium & Zinc Oxides

Antioxidants C & E

Broad Spectrum SPF 50

Water Resistant (40 Minutes)

Net Wt. 1.75 Oz./50 g

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
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-128-50	1 in 1 CARTON	03/01/2023
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	03/01/2023

Labeler - Fallien Cosmeceuticals Ltd. (958388357)

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

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