COTZ SPF 58  SUNSCREEN - titanium dioxide, 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.

----------

FALLENE CoTZ®

DRUG FACTS

Active Ingredients

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

Sunscreen

Uses: Helps prevent sunburn

  • Retains SPF up to 40 minutes of water immersion or perspiring

Warnings: For external use only

  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor.
  • Keep this and all medicines out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center

Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight

  • Continure to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.

Inactive Ingredients

Acrylates C10-30 Alkyl

Acrylates Crosspolymer,

Butylene Glycol, Butyloctyl

Salicylate, Butylparaben,

Capric/Caprylic Triglyceride,

Cetearyl Alcohol, Cetearyl

Glucoside, Cyclomethicone,

Dimethicone, EDTA,

Ethylhexyl Hydroxystearate

Benzoate, Glyceryl Stearate,

Iron Oxides, Isobutylparaben,

Isopropylparaben,

Melissa Officinalis (Balm

Mint) Extract, Octyldodecyl

Neopentanoate, PEG-100

Stearate, Phenoxyethanol,

Retinyl Palmitate,

Simethicone, Sorbitan

Laurate, Styrene/Acrylates

Copolymer, Talc, Tocopherol,

Tocopheryl Acetate,

Tricontanyl PVP, Water,

Xanthan Gum

UVA - Same Everyday

UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.

Manufactured exclusively for:
Fallien,
West Norriton, PA 19403
www.totalblock.com

Made in USA

Principal Display Panel

Principal Display Panel – Carton Label

NDC 58892-910-87

Dermatologist Recommended for Sensitive Skin

FALLENE CoTZ®

Contains Only Titanium & Zinc®

WATER-RESISTANT SUN PROTECTION

UVA-UVB SPF 58

Net Wt. 2.5 Oz./ 70 g

Figure
COTZ SPF 58   SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Butylparaben (UNII: 3QPI1U3FV8)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Carbomer Copolymer Type B (UNII: 1G56KV7BUJ)  
Cyclomethicone (UNII: NMQ347994Z)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Isobutylparaben (UNII: 0QQJ25X58G)  
Isopropylparaben (UNII: A6EOX47QK0)  
Lemon Balm Oil (UNII: MJ76269K9S)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Polyoxyl 100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Talc (UNII: 7SEV7J4R1U)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-910-871 in 1 CARTON
170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2004
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS

Revised: 8/2010
Document Id: 62bf906c-ca32-4c8f-be85-a6832d1351ff
Set id: 5dcc7e98-e4e9-4c7f-9e0f-7aa812e7cf22
Version: 1
Effective Time: 20100804
 
Fallien Cosmeceuticals, LTD.