PROCEUTICALS PRIVATE LABEL BY TIZO TINTED REPLENISHING DAILY PROTECTION- zinc oxide cream

Proceuticals Private Label by TiZO tinted replenishing daily protection by

Drug Labeling and Warnings

Proceuticals Private Label by TiZO tinted replenishing daily protection 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 INGREDIENT:Zinc Oxide 16%

PURPOSE

PURPOSE: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.

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: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane
Crosspolymer

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 cuased by the sun.

Apply liberally 15 minutes befor sun exposure.

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 50g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted replenishing
daily protection

broad spectrum spf 40
with ceramides, zinc oxide
& antioxidants C & E

net wt. 1.75 oz / 50 g

Graphic-Untitled

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO TINTED REPLENISHING DAILY PROTECTION 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CERAMIDE 3 (UNII: 4370DF050B)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-208-50	50 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(58892-208)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	manufacture(58892-208) , pack(58892-208)