Label: STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35- octinoxate and titanium dioxide paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 5.00%Sunscreen
    Titanium Dioxide 2.00%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 15 minutes before sun exposure
    • reapply 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 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
  • inactive ingredients

    octyldodecanol, synthetic beeswax, copernicia cerifera (carnauba) wax, silica, hydrogenated polyisobutene, simmondsia chinensis (jojoba) seed oil, tocopherol, ascorbyl palmitate, polybutene, pvp/hexadecene copolymer, alumina, stearic acid [+/-(may contain) titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln28455>

  • Other information

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

  • SPL UNCLASSIFIED SECTION

    DIST. BY: MAKE-UP ART COSMETICS
    TORONTO, ONTARIO, CANADA M5V 1R7

  • PRINCIPAL DISPLAY PANEL - 7 g Jar Carton

    M•A•C

    STUDIO FINISH
    CONCEALER
    SPF 35
    BROAD SPECTRUM
    SPF 35

    NET WT. 7 g/.24 US OZ e

    PRINCIPAL DISPLAY PANEL - 7 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35 
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0078-11 in 1 CARTON08/08/2011
    17 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/08/2011
    Labeler - MAKEUP ART COSMETICS (010597206)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(40046-0078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(40046-0078) , label(40046-0078)
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