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 Item Code (Source) NDC:43526-107
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.876 mg  in 40 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.8 mg  in 40 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.396 mg  in 40 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    TALC (UNII: 7SEV7J4R1U)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ARBUTIN (UNII: C5INA23HXF)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DISTEARYLDIMONIUM (UNII: 251IW5I21C)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    C12-14 PARETH-3 (UNII: 93RY22U87E)  
    PURSLANE (UNII: M6S840WXG5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ADENOSINE (UNII: K72T3FS567)  
    AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U)  
    MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
    CASTANEA SATIVA LEAF (UNII: IV3S2HH53G)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C)  
    PLANTAGO ASIATICA (UNII: 5F5728J5E8)  
    MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
    CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
    CITRUS BERGAMIA LEAF (UNII: ZGS96VDV4T)  
    FENNEL SEED (UNII: G3QC02NIE6)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
    PINUS DENSIFLORA ROOT (UNII: 23O27N8142)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    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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