PROCEUTICALS PRIVATE LABEL BY TIZO EYE REPAIR NON-TINTED MINERAL SUNSCREEN- zinc oxide cream

PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen by

Drug Labeling and Warnings

PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-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 INGREDIENT: Zinc Oxide 9%

PURPOSE

PURPOSE:Sunscreen

INDICATIONS & USAGE

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 am - 2 pm Wear long-sleeved shirts, pants, hats,
and sunglasses

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Butylene Glycol, Caffeine,
Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina
Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane,
Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone
Crosspolymer, Dimethiconol, Glycerin, Hydrogen
Dimethicone, Isododecane, Isohexadecane, Lauryl
PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl
Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20,
Saccharomyces/Selenium Ferment, Sambucus Nigra Flower
Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate,
Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

OTHER SAFETY INFORMATION

OTHER INFORMATION: Protect this product from excessive
heat and direct sun

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 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 – 15 g Bottle Label

Proceuticals

PRIVATE LABEL by TiZO

eye repair non-tinted
mineral sunscreen

broad spectrum spf 20 with
gentle zinc oxide, peptides
& botanical blend

net wt. 0.5 oz. / 15 g

Graphic-Untitled

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO EYE REPAIR NON-TINTED MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CORALLINA OFFICINALIS (UNII: 4004498D06)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANETRIOL (UNII: E52D0J3TS5)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAFFEINE (UNII: 3G6A5W338E)
ISODODECANE (UNII: A8289P68Y2)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
WATER (UNII: 059QF0KO0R)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-236-05	15 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/27/2024

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-236)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	pack(58892-236) , manufacture(58892-236)