Label: KAPLAN MD PERFECT POUT LIP BALM- octinoxate, octisalate, octocrylene lipstick

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 8, 2024

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  • Active Ingredients

    Octinoxate 7.5%

    Octisalate 5%

    Octocrylene 3%

  • Purpose

    Sunscreen

  • Warnings

    For external use only.

    Skin Cancer/Skin Agung Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to help prevent sunburn, not skin cancer or early skin aging.

  • DO NOT USE

    Do not use on damaged and broken skin.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • Other Information

    • protect the product in this container from excessive heat and direct sun
  • Directions

    • apply generously to lips 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
  • Inactive Ingredients

    Hydrogenated Polyisobutene, Ethylhexyl Methoxycinnamate, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Salicylate, Ethylhexyl Palmitate,Octocrylene, Octyldodecanol, Polyisobutene, Silica Silylate, Caprylyl Methicone, Helianthus Annuus (Sunflower) Seed Wax, Rebaudioside A, Sodium Hyaluronate, Palmitoyl Tripeptide-1, Euphorbia Cerifera Cera, Carthamus Tinctorius (Safflower) Oleoseomes, Beeswax, Aloe Barbadensis Leaf Extract*, Camellia Sinensis (Green Tea) Extract*, Salvia Officinalis (Sage) Extract*, Pelargonium Graveolens (Rose Geranium) Extract*, Melissa Officinalis (Lemon Balm) Extract*, Ginkgo Biloba Extract*, Lavandula lntermedia (Lavender) Extract*, Rosmarinus Officinalis (Rosemary) Extract*, Mentha Piperita (Peppermint) Extract*,Thymus Vulgaris (Thyme) Extract*, Chamomilla Recutita (Matricaria) Extract*,Trifolium Pratense (Red Clover) Extract*, Rosa Canina (Rose Hips) Extract*, Baraga Officinalis (Borage) Extract*, Macrocystis Pyrifera (Kelp) Extract*, Panax Ginseng Root Extract*, Camellia Sinensis (White Tea) Extract*, llex Paraguariensis (Yerba Mate) Extract*,Lippia Citriodora (Lemon Verbena) Extract*, Citrus Grandis (Grapefruit) Extract*, Sambucus Nigra (Elderflower) Extract*, Fucus Vesiculosus (Seaweed) Extract*, Phenoxyethanol, Tocopheryl Acetate, Butylene/Ethylene/Styrene Copolymer, Caprylyl Glycol, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Hexylene Glycol, Tribehenin, Glyceryl Caprylate, Sorbitan lsostearate, Silica Dimethyl Silylate, BHT, Butylene Glycol, Pentylene Glycol, Glycerin, Mentha Piperita (Peppermint) Oil, Aqua.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    apply generously to lips 15 minutes before sun exposure

  • PRINCIPAL DISPLAY PANEL

    KMDLB

  • INGREDIENTS AND APPEARANCE
    KAPLAN MD PERFECT POUT LIP BALM 
    octinoxate, octisalate, octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84300-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    RED CLOVER (UNII: L9153EKV2Y)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAGE (UNII: 065C5D077J)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    BORAGE (UNII: PB618V0K2W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WHITE TEA (UNII: O0M3396E09)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    THYME (UNII: CW657OBU4N)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84300-001-1010 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product05/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/08/2024
    Labeler - KAPLAN MD INC (782764638)
    Registrant - KDC/ONE SOCAL LABORATORIES, LLC (118384240)
    Establishment
    NameAddressID/FEIBusiness Operations
    KDC/ONE SOCAL LABORATORIES, LLC118384240manufacture(84300-001)
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