Facecotz
FDA Label NDC 58892-346

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd. for the product Facecotz (NDC 58892-346). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses:, warnings:, inactive ingredients:, spf is not enough, principal display panel – carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principal Display Panel – Carton Label (Cot01 0000 01)

Principal Display Panel – Carton Label (Cot01 0000 01)

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