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Blistex Medicated Lip Balm by Blistex Inc.

Dosage form: stick
Ingredients: Dimethicone 2g in 100g, Oxybenzone 2.5g in 100g, Padimate O 6.6g in 100g
Labeler: Blistex Inc.
NDC Code: 10157-9822

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.

Blistex®
Medicated Lip Balm

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Oxybenzone 2.5% (w/w)Sunscreen
Padimate O 6.6% (w/w)Sunscreen

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Warnings

Skin Cancer/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 help 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

Other information
  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack

Blistex® MEDICATED LIP BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

Blistex® MEDICATED LIP BALM
NET WT. .15 oz (4.25g)

SPF 15

Blistex® MEDICATED LIP BALM

©2012 Blistex Inc.
P.O. Box 5392, Oak Brook, IL
60522 C36186
23012TE

DO NOT USE IF SEAL IS MISSING.

Lift for Drug Facts

BLISTEX   MEDICATED LIP BALM
dimethicone, oxybenzone, and padimate o stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9822
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone2 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Padimate O (Padimate O) Padimate O6.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax 
cetyl alcohol 
cetyl palmitate 
candelilla wax 
isopropyl myristate 
isopropyl palmitate 
isopropyl stearate 
lanolin 
lanolin oil 
menthol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
polybutene (1400 MW) 
propylparaben 
D&C Red No. 6 
aluminum oxide 
cocoa butter 
titanium dioxide 
Product Characteristics
ColorPINKScore    
ShapeBULLETSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10157-9822-33 CYLINDER in 1 BLISTER PACK
1NDC:10157-9822-14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2010
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIOperations
Blistex Inc.005126354MANUFACTURE(10157-9822)

Revised: 04/2013
 
Blistex Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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