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

Cotz Plus 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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

Sunscreen

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    •   - After 40 minutes of swimming or sweating
    •   - Immediately after towel drying
    •   - At least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    •   - Limit time in the sun, especially from 10 a.m.-2 p.m.
    •   - Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Principal Display Panel – 2.5 oz Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ ®

PLUS

The Healthier Sunscreen TM

Balanced Mineral Complex™

#1 Rated UV Protection*

Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Oils

SPF 58 Broad

Spectrum

UVA-UVB

Blends
Translucent

Water
Resistant
(40 minutes)

Net Wt. 2.5 oz/70.0 g

Cotz Plus SPF 58

Titanium Dioxide, Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-070
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 (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
cyclomethicone
DIMETHICONE
EDETATE TRISODIUM
GLYCERYL MONOSTEARATE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
isobutylparaben
ISOPROPYLPARABEN
MELISSA OFFICINALIS LEAF
OCTYLDODECYL NEOPENTANOATE
PEG-100 STEARATE
PHENOXYETHANOL
VITAMIN A PALMITATE
SORBITAN MONOLAURATE
talc
Tocopherol
.ALPHA.-TOCOPHEROL ACETATE
tricontanyl povidone (4 tricontanyl branches/repeat)
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 70 in 1 TUBE
2 NDC:58892-070-58 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-03


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.