Label: SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20- avobenzone, homosalate, and octisalate liquid

  • 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 July 31, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 2.00%
    Homosalate 15.00%
    Octisalate 5.00%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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

    For sunscreen use:

    • apply liberally and evenly 15 minutes before sun exposure
    • apply to all skin exposed to the sun
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 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
  • Inactive Ingredients

    Cyclopentasiloxane, Polysilicone-11, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Tocopheryl Acetate, Cola Acuminata (Kola) Seed Extract, Vitis Vinifera (Grape) Seed Extract, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Octyldodecyl Neopentanoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Acetyl Hexapeptide-8, Phenyl Trimethicone, Water\Aqua\Eau, Silica, Laureth-12, Hexyl Laurate, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Caprylyl Glycol, Hexylene Glycol, Hydrogenated Polydecene, Phenoxyethanol, Potassium Sorbate, Iron Oxides (CI 77491) <ILN39369>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    Smashbox Cosmetics, Dist.
    Culver City, CA 90232

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

    smashbox

    PHOTO FINISH
    FOUNDATION PRIMER

    SPF 20
    WITH DERMAXYL™ COMPLEX

    BROAD SPECTRUM SPF 20
    1 fl. oz. / 30 ml e

    Principal Display Panel - 30 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    SMASHBOX   PHOTO FINISH FOUNDATION PRIMER SPF 20
    avobenzone, homosalate, and octisalate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    cola acuminata seed (UNII: 1F8VIW1479)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Safflower Oil (UNII: 65UEH262IS)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ceramide 2 (UNII: C04977SRJ5)  
    PEG-10 Rapeseed Sterol (UNII: 258O76T85M)  
    Palmitoyl Oligopeptide (UNII: HO4ZT5S86C)  
    Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Laureth-12 (UNII: OAH19558U1)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10348-006-011 in 1 CARTON
    150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/27/2012
    Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(10348-006) , REPACK(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Inc.042918826MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(10348-006) , RELABEL(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654REPACK(10348-006) , RELABEL(10348-006)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Cosmetics Inc078870292MANUFACTURE(10348-006)
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