Your browser does not support JavaScript! COTZ PEDIATRIC SPF 40 SUNSCREEN (ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]
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COTZ PEDIATRIC SPF 40 SUNSCREEN (zinc oxide) lotion
[Fallien Cosmeceuticals, LTD.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 ComplexTM #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

Principal Display Panel – SPF 40 100g Carton Label
COTZ PEDIATRIC SPF 40   SUNSCREEN
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58892-518
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-518-011 in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/07/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-518)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-518)

Revised: 12/2012
 
Fallien Cosmeceuticals, LTD.

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