Cotz Pediatric SPF 40 description, usages, side effects, indications, overdosage, supplying and lots more!

Cotz Pediatric SPF 40

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:

Zinc Oxide 20 %

Purpose

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:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Getyl PEG/PPG 10/1 Dimethicone, Cyelohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dlmethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydraxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

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

Principal Display Panel – SPF 40 100g Carton Label

PEDIATRICIAN RECOMMENDED

CoTZ ®

PEDIATRIC

The Healthier SunscreenTM Gentle Mineral Complex TM #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 & Fragrances

SPF 40
Broad
Spectrum
UVA-UVB

Easy to Apply
Water Resistant
(40 minutes)

Net Wt. 3.5 oz/100 g

Cotz Pediatric SPF 40

Zinc Oxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-518
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
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
CYCLOMETHICONE 6
CYCLOMETHICONE 5
DIMETHICONE 100
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER
EDETATE DISODIUM
METHICONE (20 CST)
MICROCRYSTALLINE WAX
PEG-10 DIMETHICONE (600 CST)
PEG-30 DIPOLYHYDROXYSTEARATE
POLYGLYCERYL-4 ISOSTEARATE
POLYHYDROXYSTEARIC ACID (2300 MW)
POLYSORBATE 20
SODIUM CHLORIDE
STEARYL DIMETHICONE (400 MPA.S AT 50C)
TETRAHEXYLDECYL ASCORBATE
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
TRIETHOXYCAPRYLYLSILANE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 TUBE
2 NDC:58892-518-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-09-07


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