BLISTEX  MEDICATED MINT LIP BALM- dimethicone, oxybenzone, and padimate o 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®
Medicated Lip Balm

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Oxybenzone 2.5% (w/w)Sunscreen
Padimate O 6.6% (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

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, lanolin oil, menthol, methylparaben, mineral oil, ozokerite, paraffin, petrolatum, polybutene, propylparaben, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

Other information

PRINCIPAL DISPLAY PANEL - 3 Cylinder Blister Pack

Blistex® MEDICATED LIP BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

Blistex® MEDICATED LIP BALM
NET WT. .15 oz (4.25g)

SPF 15

Blistex® MEDICATED LIP BALM

©2012 Blistex Inc.
P.O. Box 5392, Oak Brook, IL
60522 C36186
23012TE

DO NOT USE IF SEAL IS MISSING.

Lift for Drug Facts

PRINCIPAL DISPLAY PANEL - 3 Cylinder Blister Pack
BLISTEX   MEDICATED MINT LIP BALM
dimethicone, oxybenzone, and padimate o stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O6.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax (UNII: 2ZA36H0S2V)  
cetyl alcohol (UNII: 936JST6JCN)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
candelilla wax (UNII: WL0328HX19)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
isopropyl stearate (UNII: 43253ZW1MZ)  
lanolin (UNII: 7EV65EAW6H)  
lanolin oil (UNII: OVV5IIJ58F)  
menthol (UNII: L7T10EIP3A)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
propylparaben (UNII: Z8IX2SC1OH)  
D&C red no. 6 (UNII: 481744AI4O)  
aluminum oxide (UNII: LMI26O6933)  
cocoa butter (UNII: 512OYT1CRR)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeBULLETSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9608-33 in 1 BLISTER PACK
1NDC:10157-9608-14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2010
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9608)

Revised: 4/2013
Document Id: 97e6706e-e3cf-4a80-b873-36d61c13ccbb
Set id: 7dbfacc4-dc54-4dbe-b26a-628d17fea527
Version: 1
Effective Time: 20130408
 
Blistex Inc.