TIZO EYE RENEWAL SPF 20 (NON-TINTED)- zinc oxide cream

TiZO Eye Renewal SPF 20 (Non-Tinted) by

Drug Labeling and Warnings

TiZO Eye Renewal SPF 20 (Non-Tinted) 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:

Zinc Oxide 9%

Purpose:

Sunscreen

Uses:

Helps prevents 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 reach of children. If swallowed, get medical help or contact a poison control center right away.

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 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

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 Hydrogen Dimethicone,PaImitoyI Tripeptide-1, PaImitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomy- ces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Other Information:

• Protect this product from excessive heat and direct sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Principal Display Panel - 100 g Carton Label

MINERAL
PROTECTION

TIZO®

EYE RENEWAL

NON-TINTED
SPF 20

Firming Eye Repair

Mineral Sunscreen

Gentle Zinc Oxide

Peptides

Botanical Blend

Broad Spectrum SPF 20

Net Wt. 0.5 oz/15 g

INGREDIENTS AND APPEARANCE

TIZO EYE RENEWAL SPF 20 (NON-TINTED) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-113
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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAFFEINE (UNII: 3G6A5W338E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CORALLINA OFFICINALIS (UNII: 4004498D06)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ISODODECANE (UNII: A8289P68Y2)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
SILANETRIOL (UNII: E52D0J3TS5)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-113-15	1 in 1 CARTON	09/01/2020
1		15 g in 1 BOTTLE, PUMP; 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	09/01/2020

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-113)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	manufacture(58892-113) , pack(58892-113)