BLISTEX BLISSFUL BUTTERS- dimethicone, octinoxate, and oxybenzone stick

Blistex Blissful Butters by

Drug Labeling and Warnings

Blistex Blissful Butters 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 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

INGREDIENTS AND APPEARANCE

BLISTEX BLISSFUL BUTTERS 
dimethicone, octinoxate, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.6 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1104-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2015

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-1104)