Label: SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER- octinoxate and octisalate lotion

  • 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 January 23, 2012

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  • Directions

    Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

    Sun Alert

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

  • WARNING

    Keep out of eyes.

    Stop using if irritation occurs.

    If irritation persists, consult a health care practitioner.

    Keep out of reach of children.

    Apply before sun exposure.

  • ACTIVE INGREDIENTS

    7.5% Octinoxate, 5.0% Octisalate.

  • INACTIVE INGREDIENTS

    Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Perfluoroisobutyl Ether, Ethyl Perfluorobutyl Ether, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Tocophenyl Acetate, Retinyl Palmitate, Water/Aqua/Eau, Ethyl Trisiloxane, Caprylyl Methicone, Methicone, Silica, Silica Silylate, Hexylene Glycol, Propylene Glycol, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol [+/- Iron Oxides (CI77491), Titanium Dioxide (CI77891)].

  • PURPOSE

    Drug Facts

  • Warnings

    For external use only.

    When using this product

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    Rash or irritation develops and lasts.

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    Dist. Smashbox Beauty
    Cosmetics, Inc.
    Culver City, CA 90232

  • PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

    smashbox

    PHOTO FINISH
    SPF 15

    WITH DERMAXYL™ COMPLEX

    FOUNDATION PRIMER
    SPF 15 ET DERMAXYL™

    1 fl. oz./30ml e

    PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    SMASHBOX   PHOTO FINISH SPF 15 FOUNDATION PRIMER
    octinoxate and octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Diethylamino Hydroxybenzoyl Hexyl Benzoate (UNII: ANQ870JD20)  
    Safflower Oil (UNII: 65UEH262IS)  
    Cola Acuminata Seed (UNII: 1F8VIW1479)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Ceramide 2 (UNII: C04977SRJ5)  
    PEG-10 Rapeseed Sterol (UNII: 258O76T85M)  
    Palmitoyl Oligopeptide (UNII: HO4ZT5S86C)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10348-004-011 in 1 CARTON
    130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/01/2011
    Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC Kabushiki Kaisha712808195RELABEL(10348-004) , REPACK(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ARAMIS, INC042918826MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(10348-004) , RELABEL(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE787336577MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL949264774MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE618107429MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(10348-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Cosmetics Inc078870292MANUFACTURE(10348-004)
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