TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT- dimethicone gel

TiZO Photoceutical Environmental Skin Protectant by

Drug Labeling and Warnings

TiZO Photoceutical Environmental Skin Protectant 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:

Dimethicone 3%

Purpose:

Skin Protectant

Uses:

• Temporarily protects and helps relieve chapped or cracked skin.
• Helps protect from the drying effects of wind and cold weather.

Warnings:

• For external use only.

Do not use on:

• deep puncture wounds
• animal bites
• serious burns

When using this product:

• Do not get into eyes

Stop use and ask doctor if:

• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach out children.

If swallowed, get medical help or contact a poison control center right away.

Directions:

• Gently cleanse and dry affected area
• Apply liberally to affected area as needed

Inactive Ingredients:

Bisabolol, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Copper PCA Methylsilanol, Cydohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Isohexadecane, Isononyl Isononanoate, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone, Propyl Gallate, Polysorbate 20, Saccharomyces/ Copper Ferment, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer, Water

Principal Display Panel – Carton Label

ENVIRONMENTAL

SKIN PROTECTANT

TIZO®

PHOTOCEUTICAL®

Especially effective against
environmental damage

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY®

1 Fl. Oz./29 ml

Principal Display Panel – Bottle Label

TIZO®

PHOTOCEUTICAL®

ENVIRONMENTAL

SKIN PROTECTANT

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY®

1 Fl. Oz./29 ml

INGREDIENTS AND APPEARANCE

TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NP (UNII: 4370DF050B)
COPPER PIDOLATE (UNII: 497G7G1SL1)
METHYLSILANOL PCA (UNII: 837430510V)
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)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-105-30	1 in 1 CARTON	07/23/2019
1		29 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/20/2018

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(58892-105)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-105) , PACK(58892-105)