Label: SPF 15 LIGHT- titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 14, 2010

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply evenly before sun exposure and as needed. Gently swirl your Sei Bella Brush across the top and tap to remove excess.

    Make sure powder is evenly distributed on brush before applying to face. Blend foundation to the desired level of coverage.

  • CLINICAL STUDIES

    Other Information

    • dermatologist and allergy tested
  • STORAGE AND HANDLING

    Other Information

    • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Mica (CI 77019, Bismuth Oxichloride (CI 77163), Nylon-12, C12-15 Alkyl Benzoate, Phenoxyethanol, Kaolin, Silica Dimethyl Silylate, Ascorbyl Palmitate, Chlorphenesin, Potassium Sorbate, Retinyl Palmitate, Lecithin, Hyaluronic Acid (and) Echinacin, Glycerin (and) Water (and) Urea (and) Trehalose (and) Polyquaternium-51 (and) Triacetin (and) Sodium Hyaluronate, Zinc PCA, Lauryl PCA, Dimethicone (and) Water (and) Silica Dimethyl Silylate (and) Atelocollagen (and) Lysine HCI (and) Glycine (and) Sodium Chondrotin Sulfate (and) Ornithine HCI, Zinc Oxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 2, 9)

  • PRINCIPAL DISPLAY PANEL

    image of label

  • ACTIVE INGREDIENT

    Active Ingredient               Purpose

    Titanium Dioxide 7%.......Sunscreen

  • INGREDIENTS AND APPEARANCE
    SPF 15  LIGHT
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.7 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    TREHALOSE (UNII: B8WCK70T7I)  
    TRIACETIN (UNII: XHX3C3X673)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    GLYCINE (UNII: TE7660XO1C)  
    CHONDROITIN SULFATE (PORCINE) (UNII: V5E8ELO4W9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-175-0110 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/15/2010
    Labeler - Melaleuca, Inc. (139760102)
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