TIZO PHOTOCEUTICAL ENVIRONMENTAL SKIN PROTECTANT- dimethicone gel 
Fallien Cosmeceuticals, LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients:

Dimethicone 3%

Purpose:

Skin Protectant

Uses:

Warnings:

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:

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 – Carton Label

Principal Display Panel – Bottle Label

TIZO®

PHOTOCEUTICAL®

ENVIRONMENTAL

SKIN PROTECTANT

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 gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-105-301 in 1 CARTON07/23/2019
129 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/20/2018
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-105)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-105) , PACK(58892-105)

Revised: 1/2021
Document Id: a68da628-72ff-4602-bb4b-aea806cfc735
Set id: 84a3299d-9b98-492e-a83f-ebd72ec58f8d
Version: 2
Effective Time: 20210112
 
Fallien Cosmeceuticals, LTD