Label: KAPLAN MD PERFECT POUT LIP BALM PINK PEONY- 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, notskin cancer or early skin aging.

  • DO NOT USE

    Do not use ondamaged and broken skin.

  • STOP USE

    Stop use and ask a doctorif rash occurs.

  • WHEN USING

    When using this productkeep 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 PINK PEONY 
    octinoxate, octisalate, octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84300-002
    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:84300-002-1010 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(84300-002)
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