Label: JNH DR. INTENSIVE PLUS UV PROTECTOR- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 24, 2012

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  • ACTIVE INGREDIENT

    titanium dioxide
  • INACTIVE INGREDIENT

    - Water - Caprylic/Capric Triglyceride - Butylene Glycol - PEG-10 Dimethicone - Silica - Portulaca Oleracea Extract - Bacopa Monniera Extract - Dimethicone - Talc - Dihexyldecyl Lauroyl Glutamate - Sodium PCA - Hexyl Laurate - Polyglyceryl-2 Diisostearate
    - Polyglutamic Acid - Sodium Hyaluronate - Citrus Grandis (Grapefruit) Peel Extract - Camellia Sinensis Leaf Extract - Butyrospermum Parkii (Shea) Butter - Hydrogenated Lecithin - Lactobacillus/Bean Seed Extract/Sodium Glutamate Ferment Filtrate - Ceramide 3
    - Lactic Acid – Phytosphingosine - Nasturtium Officinale Flower/Leaf Extract - Niacinamide - Chlorella Vulgaris/Lupinus Albus Protein Ferment - Zinc PCA - Hydrolyzed Opuntia Ficus-Indica Flower
  • PURPOSE

    sun protect and skin care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    - Before going outside, apply suitable mount of cream on your face, neck, arms and legs where are easily exposed to sun (UV rays). (When you use it on your face, use it the last step of basic makeup)
  • WARNINGS

    When using this product
    - keep out of eyes, ears, and mouth.  If contact occurs, rinse with plenty of cold water right away and contact a physician.  If swallowing, drink plenty of water and contact a physician
  • DOSAGE & ADMINISTRATION

    for external use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    JNH DR. INTENSIVE PLUS UV PROTECTOR 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53010-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    BACOPA MONNIERA LEAF (UNII: Y04287JMZN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ETHYLHEXYL LAURATE (UNII: 8J6M396U72)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    NASTURTIUM OFFICINALE WHOLE (UNII: P7LJ54BP7G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53010-1001-150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2012
    Labeler - Daeduck Lab Co., Ltd (557819376)
    Registrant - Daeduck Lab Co., Ltd (557819376)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daeduck Lab Co., Ltd557819376manufacture(53010-1001)