Label: BLISTEX- dimethicone, octinoxate, oxybenzone, and lanolin kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 24, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts - Revive

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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!

    Principal Display Panel - Kit Package
  • INGREDIENTS AND APPEARANCE
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!