BLISTEX EUROPEAN FORMULA- lanolin, octinoxate, and oxybenzone paste

Blistex by

Drug Labeling and Warnings

Blistex by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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

SPL UNCLASSIFIED SECTION

#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)

INGREDIENTS AND APPEARANCE

BLISTEX   EUROPEAN FORMULA
lanolin, octinoxate, and oxybenzone paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9539
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H)	Lanolin	13 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9539-1	1 in 1 BLISTER PACK
1		7 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2011

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9539)