BLISTEX  REVIVE AND RESTORE- dimethicone, octinoxate, oxybenzone, and lanolin 
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®
REVIVE &
RESTORE™

Drug Facts - Revive

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

Uses

Warnings

  • Stop use if skin rash occurs

Directions

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

Drug Facts - Restore

Active ingredients

Lanolin 15.0%(w/w)

Purpose

Skin protectant

Uses

Directions

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!

Principal Display Panel - Kit Package
BLISTEX   REVIVE AND RESTORE
dimethicone, octinoxate, oxybenzone, and lanolin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9848
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9848-21 in 1 PACKAGE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 5.67 g
Part 21 JAR 5.67 g
Part 1 of 2
BLISTEX   REVIVE
dimethicone, octinoxate, and oxybenzone paste
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
15.67 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/13/2011
Part 2 of 2
BLISTEX   RESTORE
lanolin paste
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
15.67 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/13/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/13/2011
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE

Revised: 8/2011
Document Id: 28606dc7-5e71-49ce-84ae-5cc90249c18a
Set id: 38c455d3-7ec9-4493-9c06-b8aa018de7d9
Version: 1
Effective Time: 20110824
 
Blistex Inc.