CoTZ SPF 35 description, usages, side effects, indications, overdosage, supplying and lots more!

CoTZ SPF 35

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
CoTZ SPF 35 Sunscreen

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredients:

Zinc Oxide 20%.

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
  • 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 medications out of the 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
  • Continue 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 exposure, 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 fabrics

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,

Manufactured
exclusively for
Fallene, Ltd.

West Norriton, PA 19403
Made in USA

Principal Display Panel – 3.5oz Carton Label

NDC 58892-118-01

Dermatologist

Recommended for

Ultra Sensitive Skin

CoTZ®

20% Zinc Oxide

vanishing formula

Pure Mineral

Sun protection

Moisturizing

water resistant

uva/uvb

SPF 35

Net. Wt. 3.5 oz./ 100g

CoTZ SPF 35

Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-118
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 200 mg

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
CAPRYLHYDROXAMIC ACID
CAPRYLYL GLYCOL
CYCLOMETHICONE 6
CYCLOMETHICONE 5
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
HYDROXYSTEARIC ACID
POLYSORBATE 20
SODIUM CHLORIDE
TETRAHEXYLDECYL ASCORBATE
.ALPHA.-TOCOPHEROL ACETATE, D-
TROLAMINE
TRIETHOXYCAPRYLYLSILANE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 TUBE
2 NDC:58892-118-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-03-01


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