CoTZ SPF 58 description, usages, side effects, indications, overdosage, supplying and lots more!

CoTZ SPF 58

Fallien Cosmeceuticals, LTD.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
FALLENE CoTZ

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredients

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

Sunscreen

Uses

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.

  • Extra gentle - no chemical sunscreen filters
  • Dries clear
  • Oil & PABA free
  • Fragrance free

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

CoTZ SPF 58

Titanium Dioxide, Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-910
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 100 mg
Zinc Oxide Zinc oxide 30 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLENE GLYCOL
BUTYLPARABEN
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER COPOLYMER TYPE B
cyclomethicone
DIMETHICONE
EDETATE DISODIUM
GLYCERYL MONOSTEARATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
isobutylparaben
ISOPROPYLPARABEN
Lemon Balm Oil
OCTYLDODECYL NEOPENTANOATE
POLYOXYL 100 STEARATE
PHENOXYETHANOL
VITAMIN A PALMITATE
SORBITAN MONOLAURATE
talc
ALPHA-TOCOPHEROL
ALPHA-TOCOPHEROL ACETATE
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 70 in 1 TUBE
2 NDC:58892-910-87 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2004-01-02


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