OHUI SUN SCIENCE POWDER SUN BLOCK NATURAL SKIN (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) POWDER [LG HOUSEHOLD AND HEALTHCARE, INC.]

OHUI SUN SCIENCE POWDER SUN BLOCK NATURAL SKIN (OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) POWDER [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-437-01, 53208-437-02
Set ID 906fa925-a9cc-4c5a-a915-06584daf3426
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    OCTINOXATE  7g/100g

    Zinc Oxide  5g/100g

    Titanium Dioxide  2.5g/100g

    BISOCTRIZOLE  2g/100g

  • WARNINGS AND PRECAUTIONS

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL


    Ohui

    50+

    SPF 50+ PA +++

    sun science

    powder sunblock EX

    ohui sun powder

  • INGREDIENTS AND APPEARANCE
    OHUI SUN SCIENCE POWDER SUN BLOCK NATURAL SKIN 
    octinoxate, zinc oxide, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-437
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.5 g  in 100 g
    BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS) BISOCTRIZOLE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Methylparaben (UNII: A2I8C7HI9T)  
    PropylParaben (UNII: Z8IX2SC1OH)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-437-021 in 1 BOX
    1NDC:53208-437-0120 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/16/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture

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