Label: STILA SHEER COLOR TINTED MOISTURIZER BS SPF20 (ALL SHADES)- 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

    "Helps prevent sunburn"

    "If used as directed with other 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

    Stop use and ask a doctor if rash occurs

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

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • After 80 minutes of swimming or sweating
      • Immediately after towel drying
      • At least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your 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 am – 2 pm
      • Wear long-sleeved shirts, pants, hats and sunglasses
  • Inactive Ingredients

    aluminum hydroxide, anthemis nobilis (chamomile) flower extract, boron nitride, butylene glycol, camellia oleifera (camilia oleifera) leaf extract, caprylyl glycol, cyclohexasiloxane, cyclopentasiloxane, dextrin palmitate, dimethicone, ginkgo biloba leaf extract, glycerin, hexylene glycol, lysine, magnesium ascorbyl phosphate, magnesium chloride, octyldodecyl neopentanoate, palmitic acid, panax ginseng (ginseng) root extract, peg/ppg-18/18 dimethicone, phenoxyethanol, phytantriol, potassium chloride, propylene glycol, retinyl palmitate, sodium chloride, sodium dehydroacetate,sodium hyaluronate, stearic acid, tetrahexyldecyl ascorbate, tocopherol, tocopheryl acetate, triethoxycaprylylsilane, water (aqua), zinc chloride, may contain (+\-): mica, titanium dioxide (ci 77891), iron oxides (ci 77491, 77492, 77499) <iln c121004>.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Questions?

    stilacosmetics.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    stila

    sheer color
    tinted moisturizer
    broad spectrum SPF 20

    oil-free
    water-resistant (80 minutes)

    1.7 fl. oz./50 ml

    Principal Display Panel - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    STILA SHEER COLOR TINTED MOISTURIZER BS SPF20   (ALL SHADES)
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-556
    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
    aluminum hydroxide (UNII: 5QB0T2IUN0)  
    chamaemelum nobile flower (UNII: O2T154T6OG)  
    boron nitride (UNII: 2U4T60A6YD)  
    butylene glycol (UNII: 3XUS85K0RA)  
    camellia oleifera leaf (UNII: 5077EL0C60)  
    caprylyl glycol (UNII: 00YIU5438U)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    dimethicone (UNII: 92RU3N3Y1O)  
    ginkgo (UNII: 19FUJ2C58T)  
    glycerin (UNII: PDC6A3C0OX)  
    hexylene glycol (UNII: KEH0A3F75J)  
    lysine (UNII: K3Z4F929H6)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    magnesium chloride (UNII: 02F3473H9O)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    palmitic acid (UNII: 2V16EO95H1)  
    asian ginseng (UNII: CUQ3A77YXI)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    phytantriol (UNII: 8LVI07A72W)  
    potassium chloride (UNII: 660YQ98I10)  
    propylene glycol (UNII: 6DC9Q167V3)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    stearic acid (UNII: 4ELV7Z65AP)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    tocopherol (UNII: R0ZB2556P8)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    water (UNII: 059QF0KO0R)  
    zinc chloride (UNII: 86Q357L16B)  
    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:76049-556-011 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(76049-556)
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