Blistex European Formula

Dosage form: paste
Ingredients: Lanolin 13g in 100g, Octinoxate 7.5g in 100g, Oxybenzone 2.5g in 100g
Labeler: Blistex Inc.
NDC Code: 10157-9539

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®
European Formula
Lip Conditioner™

Drug Facts

Active ingredientsPurpose
Lanolin 13 .0%(w/w)Skin Protectant
Octinoxate 7.5%(w/w)Sunscreen
Oxybenzone 2.5%(w/w)Sunscreen

Uses
  • temporarily protects and helps relieve chapped or cracked lips
  • helps protect lips from the drying effects of wind and cold weather
  • helps prevent sunburn

Warnings
  • Stop use if skin rash occurs

Directions
  • apply liberally before sun exposure and as needed

Inactive ingredients

aloe barbadensis leaf extract, camphor, cetyl alcohol, cocoyl hydrolyzed soy protein, euphorbia cerifera (candelilla) wax, fragrance, isostearoyl hydrolyzed collagen, menthol, microcrystalline wax, olea europaea (olive) fruit oil, petrolatum, saccharin, theobroma cacao (cocoa) seed butter, thymol, tocopheryl acetate, vanillin, vitis vinifera (grape) seed oil

#34280
©2011 Blistex Inc.,
P.O. Box 5392,
Oak Brook, IL 60522-5392

PRINCIPAL DISPLAY PANEL - 7 g Container Label

NDC 10157-9539-1

Blistex®

LIP PROTECTANT/
SUNSCREEN

SPF
15

EUROPEAN FORMULA
LIP CONDITIONER

Moisturizes & Protects For Healthy, Beautiful Lips

Enriched with Olive & Grapeseed Oils,
Vitamin E, Cocoa Butter, Lanolin and Collagen

NET WT. .25 oz (7g)

BLISTEX   EUROPEAN FORMULA
lanolin, octinoxate, and oxybenzone paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9539
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lanolin (Lanolin) Lanolin13 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
camphor (synthetic) 
cetyl alcohol 
candelilla wax 
menthol 
microcrystalline wax 
olive oil 
petrolatum 
saccharin 
cocoa butter 
thymol 
.alpha.-tocopherol acetate 
vanillin 
grape seed oil 
Packaging
#Item CodePackage Description
1NDC:10157-9539-11 JAR (JAR) in 1 BLISTER PACK
17 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/2011
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIOperations
Blistex Inc.005126354MANUFACTURE(10157-9539)

Revised: 03/2012
 
Blistex Inc.

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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