BLISTEX DAILY CONDITIONING TREATMENT- petrolatum, 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
Octinoxate 7.3% (w/w)	Sunscreen
Oxybenzone 4.5% (w/w)	Sunscreen
Petrolatum 54.86% (w/w)	Lip protectant

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

Other information

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

Inactive ingredients

aloe barbadensis leaf extract, camphor, cetyl alcohol, cocoyl hydrolyzed soy protein, euphorbia cerifera (candelilla) wax, flavor, lanolin, menthol, ozokerite, phenol, saccharin, theobroma cacao (cocoa) seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack

NDC: 10157-9535-2

Blistex®
LIP PROTECTANT/SUNSCREEN

DCT ®

Daily
Conditioning
Treatment For Lips®

Cocoa Butter, Aloe & Vitamin E

To Maintain Healthy, Moist Lips

SPF 20

NET WT. .25 oz (7.08g)

INGREDIENTS AND APPEARANCE

BLISTEX   DAILY CONDITIONING TREATMENT
petrolatum, octinoxate, and oxybenzone paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9535
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	54.86 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.3 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
Cocoa Butter (UNII: 512OYT1CRR)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Menthol (UNII: L7T10EIP3A)
Phenol (UNII: 339NCG44TV)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9535-2	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	part347	02/14/2014

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9535)