BLISTEX LIP VIBRANCE- 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

Active ingredients	Purpose
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

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, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, polyethylene, PPG-5-ceteth-20, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil

Other information

• protect the product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 3.69g Container Blister Pack

NDC: 10157-9831-1
Blistex®
LIP PROTECTANT/SUNSCREEN

LIP
VIBRANCE™

New!

A Touch Of Color & Shimmer
That Really Lasts

Rich Moisturization & Protection

Total Care For Your Lips' Complexion

SPF 15

Built-in Mirror

NET WT. .13 oz (3.69g)

INGREDIENTS AND APPEARANCE

BLISTEX   LIP VIBRANCE
octinoxate, oxybenzone, and dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9831
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
arachidyl alcohol (UNII: 1QR1QRA9BU)
arachidyl glucoside (UNII: 6JVW35JOOJ)
docosanol (UNII: 9G1OE216XY)
butylene glycol (UNII: 3XUS85K0RA)
shea butter (UNII: K49155WL9Y)
D&C red no. 6 (UNII: 481744AI4O)
D&C red no. 7 (UNII: ECW0LZ41X8)
ethylhexyl palmitate (UNII: 2865993309)
mica (UNII: V8A1AW0880)
microcrystalline wax (UNII: XOF597Q3KY)
mineral oil (UNII: T5L8T28FGP)
panthenyl ethyl ether (UNII: F4WMF8NX3B)
paraffin (UNII: I9O0E3H2ZE)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
petrolatum (UNII: 4T6H12BN9U)
phenoxyethanol (UNII: HIE492ZZ3T)
phenyl trimethicone (UNII: DR0K5NOJ4R)
high density polyethylene (UNII: UG00KM4WR7)
PPG-5-ceteth-20 (UNII: 4AAN25P8P4)
castor oil (UNII: D5340Y2I9G)
saccharin (UNII: FST467XS7D)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
grape seed oil (UNII: 930MLC8XGG)
ferric oxide red (UNII: 1K09F3G675)
ceresin (UNII: Q1LS2UJO3A)
sandalwood (UNII: 3641YW25N2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9831-1	1 in 1 BLISTER PACK
1		3.69 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(10157-9831)