PROCEUTICALS PRIVATE LABEL BY TIZO  TINTED MINERAL SUNSCREEN - titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD

----------

DRUG FACTS

ACTIVE INGREDIENTS:

Titanium Dioxide 8%

Zinc Oxide 3.8%

PURPOSE:

Sunscreen

Sunscreen

USES:

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.

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

INACTIVE INGREDIENTS:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER INFORMATION:

Principal Display Panel – 53 g Bottle Label

PROCEUTICALS
PRIVATE LABEL by TiZO

tinted
mineral sunscreen

broad spectrum spf 40
water resistant (80 minutes)

net wt. 1.8 oz / 53 g

Principal Display Panel – 53 g Bottle Label
PROCEUTICALS PRIVATE LABEL BY TIZO   TINTED MINERAL SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
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)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
Hydrogen Dimethicone (20 cst) (UNII: 12Z59IF64N)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-203-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/04/2024
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-203)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-203) , PACK(58892-203)

Revised: 6/2024
Document Id: 323d1abf-f26a-408b-ae4d-61d12ca4ed9e
Set id: 0b62062d-b77e-4e6c-b3ab-b35ab24db7cb
Version: 1
Effective Time: 20240604
 
Fallien Cosmeceuticals, LTD