Label: STILA BRONZING TINTED MOISTURIZER OIL-FREE SPF 20- titanium dioxide and zinc oxide lotion

  • 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 November 22, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
      Titanium Dioxide 5.00%sunscreen
      Zinc Oxide 5.00%sunscreen
  • Uses

    Provides moderate protection against sunburn.

  • Sun Alert

    The sun may cause sunburn, premature aging of the skin, and skin cancer. Avoiding the sun, wearing protective clothing, and regular use of sunscreens over the years may reduce the chance of harmful effects.

  • Warnings

    For external use only.

    When using this product

    Keep out of eyes.

    Stop use and ask a doctor if

    Irritation occurs.

    Keep out of reach of children.

    Do not use on infants under 6 months old.

  • Directions

    Blend over entire face with fingertips.

  • Inactive Ingredients

    water (aqua), cyclopentasiloxane, propylene, glycol, octyldodecyl neopentanoate, peg/ppg-18/18 dimethicone, dimethicone, cyclohexasiloxane, phytantriol, magnesium ascorbyl phosphate, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, aluminum hydroxide, stearic acid, triethoxycaprylylsilane, boron nitride, glycerin, sodium dehydroacetate, palmitic acid, dextrin palmitate, sodium hyaluronate, butylene glycol, panax ginseng (ginseng) root extract, ginkgo biloba leaf extract, anthemis nobilis (chamomile) flower extract, camellia oleifera (camelia oleifera) leaf extract, magnesium chloride, potassium chloride, sodium chloride, zinc chloride, lysine, phenoxyethanol, hexylene glycol, caprylyl glycol, may contain (+/-): mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499 <iln c101014r2>.

  • SPL UNCLASSIFIED SECTION

    dist. by © stila styles, llc
    los angeles, ca 90027

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

    stila

    bronzing
    tinted moisturizer

    oil-free

    SPF 20

    1.7 fl. oz./oz. liq./50 ml e

    Principal Display Panel - 50 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    STILA BRONZING TINTED MOISTURIZER OIL-FREE SPF 20 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-554
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    dimethicone (UNII: 92RU3N3Y1O)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    phytantriol (UNII: 8LVI07A72W)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    tocopherol (UNII: R0ZB2556P8)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    aluminum hydroxide (UNII: 5QB0T2IUN0)  
    stearic acid (UNII: 4ELV7Z65AP)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    boron nitride (UNII: 2U4T60A6YD)  
    glycerin (UNII: PDC6A3C0OX)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    palmitic acid (UNII: 2V16EO95H1)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    butylene glycol (UNII: 3XUS85K0RA)  
    asian ginseng (UNII: CUQ3A77YXI)  
    ginkgo (UNII: 19FUJ2C58T)  
    chamaemelum nobile flower (UNII: O2T154T6OG)  
    camellia oleifera leaf (UNII: 5077EL0C60)  
    magnesium chloride (UNII: 02F3473H9O)  
    potassium chloride (UNII: 660YQ98I10)  
    sodium chloride (UNII: 451W47IQ8X)  
    zinc chloride (UNII: 86Q357L16B)  
    lysine (UNII: K3Z4F929H6)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    hexylene glycol (UNII: KEH0A3F75J)  
    caprylyl glycol (UNII: 00YIU5438U)  
    mica (UNII: V8A1AW0880)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76049-554-011 in 1 CARTON
    150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34708/31/2013
    Labeler - Stila Styles, LLC (809192896)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA PRODUCTS078870292MANUFACTURE(76049-554)
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