Label: HYDRO AND PORE BB  - titanium dioxide, octinoxate and zinc oxide cream 

  • NDC Code(s): 43526-107-01, 43526-107-02
  • Packager: Inel Cosmetics Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Titanium Dioxide 7.19%

    Octinoxate 7.00%

    Zinc Oxide 0.99%

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  • PURPOSE

    Sunscreen

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  • INSTRUCTIONS FOR USE

    For sunscreen use:

    - Apply liberally 15 minutes before sun exposure

    - Reapply at least every two hours

    - Use a water resistant sunscreen if swimming or sweating

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • ASK DOCTOR

    When using this product, keep out of eyes. Rinse with water to remove.

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  • INACTIVE INGREDIENT

    Water

    Cyclomethicone 5

    Glycerin

    Dipropylene glycol

    Isodecyl neopentanoate

    Talc

    Peg-10 Dimethicone (600 cst)

    Arbutin

    Dimethicone

    Ferric oxide yellow

    Distearyldimonium

    Magnesium sulfate

    C12-14 Pareth-3

    Purslane

    Phenoxyethanol

    Triethoxycaprylylsilane

    Palmitic Acid

    Ferric Oxide Red

    Ethylheylglycerin

    .Alpha, -Tocopherol acetate

    Ferrosoferric oxide

    Methicone (20 cst)

    Adenosine

    Aminopropyl dihydrogen phosphate

    Polymethysilsesquioxane (4.5 microns)

    Caviar, unspecified

    centella asiatica

    Hibiscus sabdariffa flower

    hyaluronic acid

    Mentha x rotundifolia leaf

    morinda citrifolia leaf

    undaria pinnatifida

    butylene glycol

    hyssopus officinalis flowering top

    prunus serrulata flower

    castanea sativa leaf

    morus alba leaf

    phellinus linteus mycelium

    plantago asiatica

    menthyl pyrrolidone carboxylate, (-), dl-

    citrus aurantium flower

    citrus bergamia leaf

    fennel seed

    helichrysum italicum flower

    jasminum officinale flower

    laminaria digitata

    lavandula angustifolia flowering top

    melaleuca alternifolia leaf

    pelargonium graveolens flowering top

    pinus densiflora root

    ethyl menthane carboxamide


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  • INGREDIENTS AND APPEARANCE
    HYDRO AND PORE BB  
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43526-107
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.876 mg  in 40 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 2.8 mg  in 40 mL
    Zinc Oxide (Zinc Oxide) Zinc Oxide 0.396 mg  in 40 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CYCLOMETHICONE 5  
    GLYCERIN  
    DIPROPYLENE GLYCOL  
    ISODECYL NEOPENTANOATE  
    TALC  
    PEG-10 DIMETHICONE (600 CST)  
    ARBUTIN  
    DIMETHICONE  
    FERRIC OXIDE YELLOW  
    DISTEARYLDIMONIUM  
    MAGNESIUM SULFATE  
    C12-14 PARETH-3  
    PURSLANE  
    PHENOXYETHANOL  
    TRIETHOXYCAPRYLYLSILANE  
    PALMITIC ACID  
    FERRIC OXIDE RED  
    ETHYLHEXYLGLYCERIN  
    .ALPHA.-TOCOPHEROL ACETATE  
    FERROSOFERRIC OXIDE  
    METHICONE (20 CST)  
    ADENOSINE  
    AMINOPROPYL DIHYDROGEN PHOSPHATE  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)  
    CAVIAR, UNSPECIFIED  
    CENTELLA ASIATICA  
    HIBISCUS SABDARIFFA FLOWER  
    HYALURONIC ACID  
    MENTHA X ROTUNDIFOLIA LEAF  
    MORINDA CITRIFOLIA LEAF  
    UNDARIA PINNATIFIDA  
    BUTYLENE GLYCOL  
    HYSSOPUS OFFICINALIS FLOWERING TOP  
    PRUNUS SERRULATA FLOWER  
    CASTANEA SATIVA LEAF  
    MORUS ALBA LEAF  
    PHELLINUS LINTEUS MYCELIUM  
    PLANTAGO ASIATICA  
    MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL-  
    CITRUS AURANTIUM FLOWER  
    CITRUS BERGAMIA LEAF  
    FENNEL SEED  
    HELICHRYSUM ITALICUM FLOWER  
    JASMINUM OFFICINALE FLOWER  
    LAMINARIA DIGITATA  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP  
    MELALEUCA ALTERNIFOLIA LEAF  
    PELARGONIUM GRAVEOLENS FLOWERING TOP  
    PINUS DENSIFLORA ROOT  
    ETHYL MENTHANE CARBOXAMIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43526-107-02 1 in 1 CARTON
    1 NDC:43526-107-01 40 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/25/2013
    Labeler - Inel Cosmetics Co., Ltd. (688038939)
    Registrant - Inel Cosmetics Co., Ltd. (688038939)
    Establishment
    Name Address ID/FEI Business Operations
    Inel Cosmetics Co., Ltd. 688038939 manufacture(43526-107)
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