Label: BLISTEX ULTRA RICH HYDRATION- octinoxate, oxybenzone, and dimethicone stick

  • 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 April 16, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (w/w)Lip protectant
    Octinoxate 6.8% (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 from excessive heat and direct sun
  • Inactive ingredients

    aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil

  • PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

    NDC 10157-8015-1
    Blistex®
    LIP PROTECTANT/SUNSCREEN

    ULTRA-RICH
    HYDRATION™

    NEW!

    Dual-Layer Balm

    INNER: Deeply Hydrates With
    80% Moisturizers

    OUTER: Smoothes & Seals
    With Lush Protectants

    SPF 15

    NET WT. .13 oz (3.69g)

    Principal Display Panel - 3.69 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX   ULTRA RICH HYDRATION
    octinoxate, oxybenzone, and dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.8 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    yellow wax (UNII: 2ZA36H0S2V)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ceresin (UNII: Q1LS2UJO3A)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SACCHARIN (UNII: FST467XS7D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-8015-11 in 1 BLISTER PACK
    13.69 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/30/2014
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-8015)
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