Label: COLOR CORRECTING SWIRL FOUNDATION BROAD SPECTRUM SPF 25 LIGHT- octocrylene avobenzone octisalate cream

  • 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 May 2, 2013

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  • Active Ingredients


    Octocrylene 5%

    Avobenzone 3%

    Octisalate 3%

  • 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 this product

    Keep out of eyes. Rinse with water to remove.


    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 generously 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • 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 a.m.- 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor.
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Isostearyl Neopentanoate, Isohexadecane, C12-15 Alkyl Benzoate, Butylene Glycol Cocoate, Titanium Dioxide, Hydrogenated Castor Oil, Polymethyl Methacrylate, Cetearyl Ethylhexanoate, Mica, Silica, Ceresin, Silica Dimethyl Silylate, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, PPG-15 Stearyl Ether, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Plankton Extract, Glycine Soja Oil (Glycine Soja (Soybean) Oil), Tribehenin, Retinyl Palmitate, Carthamus Tinctorius Seed Oil (Carthamus Tinctorius (Safflower) Seed Oil),Linoleic Acid, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide

    MAY CONTAIN: Titanium Dioxide, Iron Oxide, Iron Oxide, Ultramarines, Yellow 5 Lake, Yellow 6 Lake



  • Questions?

    Call Laura Geller Beauty, LLC., 1(800) MAKE UP4

  • Principal Display Panel

    LAURA GELLER

    BEAUTY INGENUITY

    cc creme compact

    color correcting swirl foundation

    braod spectrum

    SPF 25

    with sponge

    LIGHT

    Net Wt. 0.37 oz/10.5 g

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  • INGREDIENTS AND APPEARANCE
    COLOR CORRECTING SWIRL FOUNDATION BROAD SPECTRUM SPF 25  LIGHT
    octocrylene avobenzone octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CERESIN (UNII: Q1LS2UJO3A)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-119-0110.5 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/02/2013
    Labeler - LAURA GELLER MAKE UP INC. (199474524)
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