BLISTEX- dimethicone, octinoxate, oxybenzone, and lanolin kit

Blistex by

Drug Labeling and Warnings

Blistex 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 - Revive

ACTIVE INGREDIENT

Active ingredients	Purpose
Dimethicone 1.0%(w/w)	Skin protectant
Octinoxate 7.5%(w/w)	Sunscreen
Oxybenzone 2.5%(w/w)	Sunscreen

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps protect lips from the drying effects of wind and cold weather
• helps prevent sunburn

Warnings

• Stop use if skin rash occurs

Directions

• apply liberally before sun exposure and as needed
• children under six months of age:
  ask a doctor

Inactive ingredients

acer saccharum (sugar maple) extract, aloe barbadensis leaf extract, beeswax, bis-diglyceryl polyacyladipate-2, butyrospermum parkii (shea butter), C10-30 cholesterol/lanosterol esters, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, citrus aurantium dulcis (orange) fruit extract, citrus medica limonum (lemon) extract, flavors, menthol, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, purified water, ricinus communis (castor) seed oil, saccharin, saccharum officinarum (sugar cane) extract, vaccinium myrtillus (bilberry) extract

SPL UNCLASSIFIED SECTION

Drug Facts - Restore

Active ingredients

Lanolin 15.0%(w/w)

Purpose

Skin protectant

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps protect lips from the drying effects of wind and cold weather

Directions

• apply as needed

Inactive ingredients

beeswax, bis-diglyceryl polyacyladipate-2, brassica campestris/aleurites fordi oil copolymer, C10-30 cholesterol/lanosterol esters, flavors, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, saccharin, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - Kit Package

NDC: 10157-9848-2

Blistex®
REVIVE: LIP PROTECTANT/SUNSCREEN
RESTORE: LIP PROTECTANT

REVIVE &
RESTORE™

REVIVE FORMULA
Leaves lips smooth, invigorated & protected
Shea butter, fruit extracts & SPF 15

RESTORE FORMULA
Makes lips soft, healthy & radiant
Phyto-nutrients & Vitamin E

JARS NEST
AND LOCK
TOGETHER

2 JARS
NET WT.
.20 oz.
(5.67g)ea.

NEW!

INGREDIENTS AND APPEARANCE

BLISTEX   REVIVE AND RESTORE
dimethicone, octinoxate, oxybenzone, and lanolin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9848

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9848-2	1 in 1 PACKAGE

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 JAR	5.67 g
Part 2	1 JAR	5.67 g

Part 1 of 2

BLISTEX   REVIVE
dimethicone, octinoxate, and oxybenzone paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)
MENTHOL (UNII: L7T10EIP3A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CASTOR OIL (UNII: D5340Y2I9G)
SACCHARIN (UNII: FST467XS7D)
SUGARCANE (UNII: 81H2R5AOH3)
BILBERRY (UNII: 9P2U39H18W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5.67 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/13/2011

Part 2 of 2

BLISTEX   RESTORE
lanolin paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN (UNII: FST467XS7D)
JOJOBA OIL (UNII: 724GKU717M)
SQUALANE (UNII: GW89575KF9)
COCOA BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5.67 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/13/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/13/2011

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE