BLISTEX LIP VIBRANCE- dimethicone, octinoxate, and octisalate stick

Blistex Lip Vibrance by

Drug Labeling and Warnings

Blistex Lip Vibrance 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

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, butylene glycol, butyrospermum parkii (shea) butter, D&C red no. 6, D&C red no. 7, ethylhexyl palmitate, flavors, hydrogenated polyisobutene, iron oxides, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

LIP
VIBRANCE®

A Touch Of Color & Shimmer
That Really Lasts

Rich Moisturization & Protection

ENHANCEMENT SERIES®

SPF 15

Built-in Mirror

Net Wt. 0.13 oz. (3.69 g)

INGREDIENTS AND APPEARANCE

BLISTEX LIP VIBRANCE 
dimethicone, octinoxate, and octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1124
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
MINERAL OIL (UNII: T5L8T28FGP)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PETROLATUM (UNII: 4T6H12BN9U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
GRAPE SEED OIL (UNII: 930MLC8XGG)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 6 (UNII: 481744AI4O)
CASTOR OIL (UNII: D5340Y2I9G)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIN (UNII: FST467XS7D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1124-1	1 in 1 BLISTER PACK	07/20/2018
1		3.69 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 10157-1124-2	2 in 1 BLISTER PACK	07/20/2018
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	07/20/2018

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1124)