PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen by

Drug Labeling and Warnings

PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen 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:
Titanium Dioxide 10%
Zinc Oxide 3%

PURPOSE

PURPOSE:Sunscreen

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:
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 SAFETY INFORMATION

OTHER INFORMATION:
Protect this product from excessive heat and direct sun
May stain some fabrics

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 caused by the sun.

Apply liberally 15 minutes before sun exposure.

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 53 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

daily defense tinted
mineral sunscreen

broad spectrum spf 50
water resistant (40 minutes)

net wt. 1.8 oz / 53 g

Graphic-Untitled

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO DAILY DEFENSE TINTED MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-258
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-258-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/08/2024

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-258)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	pack(58892-258) , manufacture(58892-258)