BLISTEX NURTURE AND NOURISH- octinoxate, oxybenzone, and dimethicone stick

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

• Dimethicone 2.0% (w/w): Lip protectant
• Octinoxate 7.5% (w/w): Sunscreen
• Oxybenzone 2.5% (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, euterpe oleracea (acai) fruit extract, flavor, helianthus annuus (sunflower) seed oil, hydrogenated vegetable oil, jojoba esters, lanolin alcohol, lycium barbarum (goji) fruit extract, microcrystalline wax, octyldodecanol, olea europaea (olive) fruit oil, ozokerite, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, saccharomyces/copper ferment, saccharomyces/magnesium ferment, saccharomyces/potassium ferment, saccharomyces/zinc ferment, sorbic acid, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vitis vinifera (grape) seed oil

Other information

• protect the product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 4.25g Stick Carton

Exceptionally
Healthy Lips
Inside & Out

Blistex®

INGREDIENTS AND APPEARANCE

BLISTEX   NURTURE AND NOURISH
octinoxate, oxybenzone, and dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9826
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
yellow wax (UNII: 2ZA36H0S2V)
acai (UNII: 46AM2VJ0AW)
sunflower oil (UNII: 3W1JG795YI)
lanolin alcohols (UNII: 884C3FA9HE)
lycium barbarum fruit (UNII: 930626MWDL)
microcrystalline wax (UNII: XOF597Q3KY)
octyldodecanol (UNII: 461N1O614Y)
olive oil (UNII: 6UYK2W1W1E)
petrolatum (UNII: 4T6H12BN9U)
phenoxyethanol (UNII: HIE492ZZ3T)
castor oil (UNII: D5340Y2I9G)
saccharin (UNII: FST467XS7D)
sorbic acid (UNII: X045WJ989B)
squalane (UNII: GW89575KF9)
cocoa butter (UNII: 512OYT1CRR)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
grape seed oil (UNII: 930MLC8XGG)
ceresin (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9826-1	1 in 1 CARTON
1		4.25 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/31/2013

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9826)