QUEENS ROSE WHOLE IN ONE SUNBLOCK (OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE) CREAM [CDPHARMTEC CO.,LTD]

QUEENS ROSE WHOLE IN ONE SUNBLOCK (OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE) CREAM [CDPHARMTEC CO.,LTD]
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NDC 71252-100-01, 71252-100-02
Set ID 80e4f4fd-16d2-4c9f-bf4b-e19dce87d9e5
Category HUMAN OTC DRUG LABEL
Packager Cdpharmtec Co.,ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 5.50%, Ethylhexyl Salicylate 5.00%, Phenylbenzimidazole Sulfonic Acid 4.00%, Butyl Methoxydibenzoylmethane 3.00%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Butylene Glycol,Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-15 Alkyl Benzoate,Arbutin,Cetearyl Alcohol,Glycerin,Glyceryl Stearate,Cetearyl Olivate,Polysorbate 60, Sorbitan Olivate,PEG-100 Stearate,Sorbitan Stearate,Sodium Hydroxide,Dimethicone, Methyl Methacrylate Crosspolymer, VP/Hexadecene Copolymer, Polyacrylate-13, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polyisobutene, Ceramide NP, Human Stem Cell Conditioned Media, Disodium EDTA, 1,2-Hexanediol, Tocopheryl Acetate, Phospholipids, Adenosine, Polysorbate 20, BHT, Phytosphingosine, Sorbitan Isostearate, CI 17200

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns.

    Keep out of reach of children

  • DESCRIPTION

    Indications & Usage: Helps prevent and relieve chapped or cracked skin.

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    QUEENS ROSE WHOLE IN ONE SUNBLOCK 
    octinoxate, octisalate, ensulizole, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71252-100
    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) ENSULIZOLE2.0 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:71252-100-021 in 1 CARTON03/02/2017
    1NDC:71252-100-0150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/02/2017
    Labeler - Cdpharmtec Co.,ltd (694209262)
    Registrant - Cdpharmtec Co.,ltd (694209262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cdpharmtec Co.,ltd694209262relabel(71252-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71252-100)

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