BLISTEX  MEDICATED BERRY BALM- dimethicone, padimate o, and oxybenzone 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 Berry 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, flavor, 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 - 4.25 g Cylinder Carton

Blistex® MEDICATED BERRY BALM

NET WT. .15 oz (4.25g)

SPF 15

Principal Display Panel - 4.25 g Cylinder Carton
BLISTEX   MEDICATED BERRY BALM
dimethicone, padimate o, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9713
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O6.6 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
D&C RED NO. 6 (UNII: 481744AI4O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
COCOA BUTTER (UNII: 512OYT1CRR)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScore    
ShapeBULLETSize
FlavorRASPBERRY (fruity) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9713-33 in 1 CARTON
1NDC:10157-9713-14.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2010
Labeler - Blistex Inc (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc005126354MANUFACTURE(10157-9713)

Revised: 3/2013
Document Id: 0b49344c-a36c-44ed-8ee1-222f6b260f92
Set id: 3384a53e-b959-44de-92a6-84a6cfff2b83
Version: 1
Effective Time: 20130313
 
Blistex Inc