TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED- zinc oxide cream 
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.

----------

DRUG FACTS

Active Ingredients:

Zinc Oxide 16%

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:

Inactive Ingredients:

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

Other Information:

Principal Display Panel – Carton Label

AM
REPLENISH

Non-Tinted
SPF 40

TIZO®

PHOTOCEUTICAL®

Enhances, protects &
neutralizes free radicals

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

Broad Spectrum SPF 40

Net Wt. 1.75 oz/50 g

Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

TIZO®

PHOTOCEUTICAL

AM
REPLENISH

Non-Tinted

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

SPF 40
Broad Spectrum

1.75 Fl. Oz/50 mL

Principal Display Panel – Tube Label
TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide160 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CERAMIDE NP (UNII: 4370DF050B)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone 20 (UNII: H8YMB5QY0D)  
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-107-501 in 1 CARTON07/23/2019
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/05/2018
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-107)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-107) , PACK(58892-107)

Revised: 1/2021
Document Id: 4b6239f5-95d9-4e4d-94eb-7f03ab64bab2
Set id: c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6
Version: 2
Effective Time: 20210112
 
Fallien Cosmeceuticals, LTD