BLISTEX  EUROPEAN FORMULA- lanolin, octinoxate, and oxybenzone paste 
Blistex 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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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

Warnings

Directions

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)

Principal Display Panel - 7 g Container Label
BLISTEX   EUROPEAN FORMULA
lanolin, octinoxate, and oxybenzone paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9539
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin13 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
camphor (synthetic) (UNII: 5TJD82A1ET)  
cetyl alcohol (UNII: 936JST6JCN)  
candelilla wax (UNII: WL0328HX19)  
menthol (UNII: L7T10EIP3A)  
microcrystalline wax (UNII: XOF597Q3KY)  
olive oil (UNII: 6UYK2W1W1E)  
petrolatum (UNII: 4T6H12BN9U)  
saccharin (UNII: FST467XS7D)  
cocoa butter (UNII: 512OYT1CRR)  
thymol (UNII: 3J50XA376E)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
vanillin (UNII: CHI530446X)  
grape seed oil (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9539-11 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/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9539)

Revised: 3/2012
Document Id: 374e1e4e-e5c2-4089-a86c-a86ed39d67c9
Set id: 197a2d5b-cd4b-431e-940b-f76684db7451
Version: 2
Effective Time: 20120316
 
Blistex Inc.