ULTRA RICH HYDRATION (DIMETHICONE, OCTINOXATE, AND OCTISALATE) STICK [BLISTEX INC.]

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ULTRA RICH HYDRATION (DIMETHICONE, OCTINOXATE, AND OCTISALATE) STICK [BLISTEX INC.]
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NDC 10157-1133-1, 10157-1133-2
Set ID a85e0e37-3382-48fd-b2bc-e559e577baa4
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (w/w)Lip protectant
    Octinoxate 6.6% (w/w)Sunscreen
    Octisalate 4.4% (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

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

  • PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    ENHANCEMENT SERIES®

    ULTRA-RICH
    HYDRATION®

    DUAL-LAYER BALM

    INNER: 80% Moisturizers

    OUTER: Lush Protectants

    SPF 15

    Net Wt. 0.13 oz. (3.69 g)

    PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    ULTRA RICH HYDRATION 
    dimethicone, octinoxate, and octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.6 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SACCHARIN (UNII: FST467XS7D)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1133-11 in 1 BLISTER PACK10/17/2018
    13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:10157-1133-22 in 1 BLISTER PACK10/17/2018
    23.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/17/2018
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-1133)
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