Label: SEI BELLA TINTED BB MOISTURIZING CREME MEDIUM 300 W- titanium dioxide 5% and zinc oxide 5% lotion

  • NDC Code(s): 54473-285-01, 54473-285-30
  • Packager: Melaleuca Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 30, 2024

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  • Active Ingredient

    Titanium Dioxide 5%

    Zinc Oxide 5%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions​), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply smoothly on cleansed skin
    • apply liberally 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

    Other information

    • for normal to oily skin
    • dermatologist tested
    • may stain some fabrics

    • protect this product from excesssive heat and direct sun
    • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
  • Inactive ingredients

    Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Tocopherol, Tetrahexyldecyl Ascorbate, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Aluminum Hydroxide, Hexylene Glycol, Disodium EDTA, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

    May Contain (+/-): Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    Sei Bella Tinted BB Moisturizing Cream tube.jpgSei Bella Tinted BB Moisturizing Cream box.jpg

  • INGREDIENTS AND APPEARANCE
    SEI BELLA TINTED BB MOISTURIZING CREME  MEDIUM 300 W
    titanium dioxide 5% and zinc oxide 5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.5 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-285-011 in 1 BOX05/01/2018
    1NDC:54473-285-3030 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2018
    Labeler - Melaleuca Inc. (139760102)
    Registrant - Melaleuca Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mana078870292manufacture(54473-285)
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