Drug Labeling and Warnings

Drug Details

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SOLAR PROTECTION FORMULA TIZO SHEERFOAM  SUNSCREEN - titanium dioxide, zinc oxide aerosol, foam 
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:

Titanium Dioxide 3%

Zinc Oxide 10%

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:

  • Flammable: Do not use near heat, flame, or while smoking. Do not puncture or incinerate; contents under pressure. Do not store at temperatures above 120° F.
  • 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:

  • Shake well before using.
  • Align arrows to remove cap.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Store between 68° to 104° F (20° to 40° C).

Inactive Ingredients:

Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Isobutane, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Propane, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water

Manufactured exclusively for Fallien Cosmeceuticals LTD.
West Norriton, PA 19403

Principal Display Panel – 100g Carton Label

NDC: 58892-130-01

SOLAR

PROTECTION

FORMULA®

TIZO®

protection

Delicate Mineral
Fusion

SheerFoamTM

SPF 30
Broad Spectrum

Water Resistent
(40 minutes)

Net Wt. 3.5 oz./100g

Principal Display Panel – 100g Carton Label
SOLAR PROTECTION FORMULA TIZO SHEERFOAM   SUNSCREEN
titanium dioxide, zinc oxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58892-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glycereth-26 (UNII: NNE56F2N14)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Isobutane (UNII: BXR49TP611)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propane (UNII: T75W9911L6)  
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Trimethoxycaprylylsilane (UNII: FZ07E4LW2M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58892-130-011 in 1 CARTON
1100 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/20/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
ARI115315822PACK(58892-130)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-130)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-130)

Revised: 12/2012
 
Fallien Cosmeceuticals, LTD.


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