FDA Label for Facecotz (sunscreen)
View Indications, Usage & Precautions
Facecotz (sunscreen) Product Label
The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
Other Information: May stain some fabrics
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.
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
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
* Please review the disclaimer below.