Label: FACECOTZ- titanium dioxide, zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 58892-346-45 - Packager: Fallien Cosmeceuticals, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 2, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses:
-
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.
-
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.
- Excellent for Sensitive Skin
- Free of "Chemical Sunscreen Filters"
- Contains no Parabens
- Dries Translucent
- Full Spectrum Protection
Made in U.S.A.
Patented
Manufactured exclusively for
Fallene Ltd.,
West Norriton, PA
Made in USA PATENTED - Principal Display Panel – Carton Label
-
INGREDIENTS AND APPEARANCE
FACECOTZ (SUNSCREEN)
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-346 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 85.4 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 40.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aluminum Oxide (UNII: LMI26O6933) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-346-45 1 in 1 CARTON 1 44.4 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2009 Labeler - Fallien Cosmeceuticals, LTD. (958388357) Establishment Name Address ID/FEI Business Operations Process Technologies & Packaging 809172885 MANUFACTURE, PACK Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS
