Your browser does not support JavaScript! KIDS SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [KAREWAY PRODUCT, INC.]
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KIDS SUNSCREEN (octinoxate and titanium dioxide) lotion
[Kareway Product, Inc.]


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

Active Ingredients

Octyl Methoxycinnamate 7%

Titanium Dioxide 2.8%

Purpose

Sunscreen

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Early Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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
  • may stain fabrics
  • for Lot and Expiration Date, see crimp of tube

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

Pure Aid 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 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.8 g  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: 02/2013
Document Id: 1e2791e7-8a1e-4b54-96a0-2313bf4e5f94
Set id: 6d99a7c2-7c49-410f-9c36-fe83213c8a76
Version: 2
Effective Time: 20130227
 
Kareway Product, Inc.

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