Label: DEEP RENEWAL BROAD SPECTRUM- dimethicone, avobenzone, homosalate, and octisalate stick

  • NDC Code(s): 10157-1170-1, 10157-1170-2
  • Packager: Blistex Inc
  • 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 September 11, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0% (w/w)Sunscreen
    Dimethicone 2.0% (w/w)Lip protectant
    Homosalate 9.0% (w/w)Sunscreen
    Octisalate 4.4% (w/w)Sunscreen
  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent sunburn
  • Warnings

    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
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.-2 p.m.
      • wear long sleeve shirts, pants, hats, and sunglasses
    • 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

    atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, silica, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

  • PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    DEEP
    RENEWAL®

    FOR YOUNGER LOOKING LIPS

    Smooths & Softens Lips

    Moisturizes, Protects
    & Revitalizes

    ENHANCEMENT SERIES®

    coenzyme
    Q∙10

    with
    Hyaluronic
    Spheres

    BROAD
    SPECTRUM
    SPF 15

    Net Wt. 0.13 oz. (3.69 g)

    Principal Display Panel - 3.69 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    DEEP RENEWAL BROAD SPECTRUM 
    dimethicone, avobenzone, homosalate, and octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    CHONDROITIN SULFATE SODIUM, SHARK (UNII: Q75WVO004L)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    SACCHARIN (UNII: FST467XS7D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1170-11 in 1 BLISTER PACK09/09/2020
    13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:10157-1170-22 in 1 BLISTER PACK09/09/2020
    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 FINALpart34709/09/2020
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-1170)
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