BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS (OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE) CREAM [PHARMICELL CO., LTD.]

BY PHARMICELL LAB PRESTIGE SUN BLOCK SPF40 PA PLUS PLUS PLUS (OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE) CREAM [PHARMICELL CO., LTD.]
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NDC 60949-030-01
Set ID 6f9d3195-418d-446e-817c-e0fddb68ee14
Category HUMAN OTC DRUG LABEL
Packager Pharmicell Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredient : OCTINOXATE 5.5%, OCTISALATE 5.0%, ENSULIZOLE 4.0%, AVOBENZONE 3%

  • INACTIVE INGREDIENT

    Inactive ingredient : WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, ARBUTIN, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CETEARYL OLIVATE, GLYCERIN, SORBITAN OLIVATE, CYCLOHEXASILOXANE, GLYCERYL STEARATE, SODIUM HYDROXIDE, DIMETHICONE, PANTHENOL, METHYL METHACRYLATE CROSSPOLYMER, VP/HEXADECENE COPOLYMER, POLYSORBATE 60, POLYACRYLATE-13, PHENOXYETHANOL, SORBITAN STEARATE, POLYISOBUTENE, DISODIUM EDTA, TOCOPHERYL ACETATE, SODIUM BENZOATE, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, PEG-100 STEARATE, POTASSIUM SORBATE, CITRUS AURANTIFOLIA (LIME) FLOWER EXTRACT, ADENOSINE, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PRUNUS PERSICA (PEACH) FLOWER EXTRACT, BHT, SORBITAN ISOSTEARATE, POLYSORBATE 20, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, PYRUS MALUS (APPLE) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, 1,2-HEXANDIOL, CAPRYLYL GLYCOL, CITRUS AURANTIFOLIA (LIME) OIL, PUNICA GRANATUM FLOWER EXTRACT, PINUS SYLVESTRIS LEAF OIL, PRUNUS AVIUM (SWEET CHERRY) FLOWER EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FLOWER EXTRACT, HYDROLYZED EXTENSIN, ALOE BARBADENSIS LEAF JUICE, EUCALYPTUS GLOBULUS LEAF OIL, ZEA MAYS (CORN) KERNEL EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, SQUALANE, PHOSPHOLIPIDS, CI 17200, PHYTOSPHINGOSINE, CERAMIDE 3, TROPOLONE, PHYTOSTEROLS, ETHYLHEXYLGLYCERIN

  • PURPOSE

    Purpose : Sunscreen

  • WARNINGS

    Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and babies.

  • INDICATIONS AND USAGE

    Indications and usage : At the last step of basic skin care, take a proper amount of the sun block and spread it evenly over the skin.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BY PHARMICELL LAB PRESTIGE SUN BLOCK  SPF40 PA PLUS PLUS PLUS
    octinoxate, octisalate, ensulizole, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.75 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 50 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-030-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2013
    Labeler - Pharmicell Co., Ltd. (687744110)
    Registrant - Pharmicell Co., Ltd. (687744110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmicell Co., Ltd.687744110manufacture(60949-030)

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