BLISTEX  LIP VIBRANCE- octinoxate, oxybenzone, and dimethicone stick 
Blistex Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Blistex®
Lip Vibrance

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

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

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

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)

PRINCIPAL DISPLAY PANEL - 3.69g Container Blister Pack
BLISTEX   LIP VIBRANCE
octinoxate, oxybenzone, and dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9831
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9831-11 in 1 BLISTER PACK
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/31/2013
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9831)

Revised: 3/2013
Document Id: 4365e238-9de4-4d27-98ce-c684f33b61bd
Set id: efc150e3-56e9-45bb-9064-951d5f665682
Version: 1
Effective Time: 20130326
 
Blistex Inc.