BLISTEX BLISSFUL BUTTERS- dimethicone, octinoxate, 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® Blissful Butters

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Oxybenzone 3.0% (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

aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, astrocaryum tucuma seed butter, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyrospermum parkii (shea) butter, C10-30 cholesterol/lanosterol esters, cetyl dimethicone, cetyl palmitate, flavors, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, mangifera indica (mango) seed butter, microcrystalline wax, myristyl myristate, octyldodecanol, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, polyhydroxystearic acid, saccharin, silica, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

NDC 10157-1104-1

Blistex®

LIP PROTECTANT/
SUNSCREEN

New!

Blissful
Butters®

Enriched Triple Blend Of
Shea, Mango & Tucuma Butters

Rich, Velvety Formula
Deeply Moisturizes & Protects

Net Wt. 0.15 oz. (4.25 g)
SPF 15

Principal Display Panel - 4.25 g Cylinder Carton
BLISTEX BLISSFUL BUTTERS 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PETROLATUM (UNII: 4T6H12BN9U)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SACCHARIN (UNII: FST467XS7D)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SHEA BUTTER (UNII: K49155WL9Y)  
ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-1104-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product07/01/201512/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/201512/01/2020
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-1104)

Revised: 12/2020
Document Id: 161c75e0-735e-4368-8d92-78f251648654
Set id: 7a6f1105-51f6-4d22-a47a-74066b1043c4
Version: 3
Effective Time: 20201201
 
Blistex Inc.