FACECOTZ  (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.

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FaceCŌTZ (Sunscreen)

DRUG FACTS

Active Ingredient

Titanium Dioxide 8%

Zinc Oxide 3.8%

Purpose

Sunscreen

Sunscreen

Uses:

Helps to prevent and reduce the damaging effects of the sun's Ultraviolet light, including wrinkles and reactions associated with sun damage.

Warnings:

For external use only. Avoid contact with eyes. In case of contact, flush eyes thoroughly. Do not use if sensitive to ingredients. If irritation occurs, discontinue use. If irritation persists, see doctor. Keep this and all mediciations out of reach of children.

Directions:

Apply before exposure to sunlight. Apply uniformly and completely to all exposed skin areas. Reapply every 2-3 hours and after washing, swimming, sweating, or towel drying for maximum protection.

Other Information: May stain some fabrics

Inactive Ingredients:

Alumina, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolyner, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

FACECŌTZ is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. FACECŌTZ offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized titanium dioxide and zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. FACECŌTZ is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.

SPF is not Enough

UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is reasonsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and zinc oxide, are the best method of assuring full spectrum sun protection, from UVA and UVB radiation.

Made in U.S.A.

Patented

Manufactured exclusively for
Fallene Ltd.,
West Norriton, PA
Made in USA PATENTED

Principal Display Panel – Carton Label

NDC 58892-346-45

Dermatologist

Recommended for Sensitive Skin

FACE

CŌTZ

Contains Only Titanium & ZincTM

VERY WATER-RESISTANT SUN PROTECTION

UVA-UVB

SPF40

1.5 FL. OZ./44.4 ML

Principal Display Panel – Carton Label
FACECOTZ   (SUNSCREEN)
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-346
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide85.4 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide40.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide (UNII: LMI26O6933)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-346-451 in 1 CARTON
144.4 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2009
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS

Revised: 9/2010
Document Id: 769c18c0-c9d3-4866-99e8-eb2b8680f58b
Set id: 01816579-3a7b-414a-9287-7d493cc1dd05
Version: 1
Effective Time: 20100902
 
Fallien Cosmeceuticals, LTD.