Label: ONALT PURE MILD SUNCREAM- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 21, 2020

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  • ACTIVE INGREDIENT

    titanium dioxide, zinc oxide

  • PURPOSE

    UV protection

    skin whitening

    wrinkle care

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • WARNINGS

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    Water
    C12-15 Alkyl Benzoate
    Cyclopentasiloxane
    Glycerin
    Methylpropanediol
    Cetyl PEG/PPG-10/1 Dimethicone
    Aluminum Hydroxide
    Polyhydroxystearic Acid
    Niacinamide
    Cetyl Dimethicone
    Sea Water
    Cetyl Ethylhexanoate
    Sorbitan Trioleate
    Stearic Acid
    Isostearic Acid
    Sorbitan Sesquioleate
    Trifluoropropyl Dimethicone
    Benzyl Glycol
    Disteardimonium Hectorite
    Ozokerite
    Sodium Chloride
    Butylene Glycol
    Silica Dimethyl Silylate
    Polymethylsilsesquioxane
    Fragrance
    Silica
    Tocopheryl Acetate
    Sargassum Fulvellum Extract
    Ethylhexylglycerin
    Hizikia Fusiforme Extract
    1,2-Hexanediol
    Adenosine
    Disodium EDTA
    Ethylhexylglycerin

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ONALT PURE MILD SUNCREAM 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80564-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80564-0001-150 mL in 1 TUBE; Type 0: Not a Combination Product09/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/22/2020
    Labeler - HnB9 Co., Ltd. (694434516)
    Registrant - HnB9 Co., Ltd. (694434516)
    Establishment
    NameAddressID/FEIBusiness Operations
    HnB9 Co., Ltd.694434516manufacture(80564-0001)
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