KIDS SUNSCREEN - octinoxate and titanium dioxide lotion 
Kareway Product, Inc.

Disclaimer: 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.

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Active Ingredients

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or call 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

Other information

protect this product from excessive heat and direct sun

Inactive Ingredients

beeswax, carbomer, cetyl alcohol, dimethicone, disodium edta, fragrance, glycerin, glyceryl stearate se, glyceryl stearate and peg-100 stearate, methylparaben, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Package label

Kids Sunscreen Lotionimage of sunscreen tube

KIDS SUNSCREEN 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
CETYL ALCOHOL 
DIMETHICONE 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0082-5100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 12/2011
Document Id: e9753cbc-5a89-45c1-a882-93de1b2dff2a
Set id: 6d99a7c2-7c49-410f-9c36-fe83213c8a76
Version: 1
Effective Time: 20111201
 
Kareway Product, Inc.