BLISTEX GLOBAL BLEND- dimethicone, octinoxate, and octisalate stick

Blistex Global Blend by

Drug Labeling and Warnings

Blistex Global Blend 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
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 6.6% (w/w)	Sunscreen
Octisalate 4.4% (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

Other information

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

Inactive ingredients

beeswax, bis-stearyl dimethicone, flavors, hydrogenated polyisobutene, jojoba esters, mangifera indica (mango) seed butter, mica, microcrystalline wax, myristyl myristate, octyldodecanol, pearl powder, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, ricinus communis (castor) seed oil, saccharin, simmondsia chinensis (jojoba) seed oil, sorbic acid, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

GLOBAL
BLEND™

New!

Nurturing Ingredients
From Around The World

African Mango Butter,
South American Jojoba Oil
& Asian Pearl Powder

SPF 15

Net Wt. 0.13 oz. (3.69 g)

INGREDIENTS AND APPEARANCE

BLISTEX GLOBAL BLEND 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTYLDODECANOL (UNII: 461N1O614Y)
WHITE WAX (UNII: 7G1J5DA97F)
CASTOR OIL (UNII: D5340Y2I9G)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN (UNII: FST467XS7D)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1134-1	1 in 1 BLISTER PACK	07/01/2018
1		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1134-2	2 in 1 BLISTER PACK	09/20/2019
2		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	07/01/2018

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1134)