Label: ABSOLUTE FINISH FOUNDATION SPF15- octinoxate and titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active Ingredients

    Octinoxate 7.5%, Titanium Dioxide 2.0%

    Close
  • Purpose

    Sunscreen

    Close
  • Uses

    • 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
    Close
  • 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.

    Close
  • Directions

    Apply liberally 15 minutes before sun exposure

    • reapply: after 40 minutes of swimming or sweating
    • immediately after towel drying
    • 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 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor
    Close
  • Inactive Ingredients

    Cyclopentasiloxane, Tribehenin, Dimethicone Crosspolymer, Cyclohexasiloxane, Octyldodecyl Neopentanoate, Emu Oil, Dimethicone, Tocopheryl Acetate, Retinyl Palmitate, Ascorbic Acid, Salicylic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol, Mica, Titanium Dioxide, Iron Oxides.

    Close
  • Other information

    • protect this product from excessive heat and direct sun
    Close
  • Questions or comments?

    Call toll free at 866-452-7956.

    Close
  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED IN U.S.A.
    BY ERNO LASZLO NEW YORK, NY 10001

    Close
  • PRINCIPAL DISPLAY PANEL - 15 mL Jar Carton

    ERNO
    LASZLO

    NEW YORK

    ABSOLUTE FINISH

    FOUNDATION SPF 15

    15mL e 0.5 fl.oz.

    Principal Display Panel - 15 mL Jar Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ABSOLUTE FINISH FOUNDATION SPF15 
    octinoxate and titanium dioxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2900
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (Octinoxate) Octinoxate 75 mg  in 1 mL
    Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Cyclomethicone 5  
    Tribehenin  
    Cyclomethicone 6  
    Octyldodecyl Neopentanoate  
    Emu Oil  
    Dimethicone  
    .Alpha.-Tocopherol Acetate  
    Vitamin A Palmitate  
    Ascorbic Acid  
    Salicylic Acid  
    Triethoxycaprylylsilane  
    Phenoxyethanol  
    Caprylyl Glycol  
    Hexylene Glycol  
    Mica  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57913-2900-9 1 in 1 CARTON
    1 15 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/10/2013
    Labeler - Erno Laszlo, Inc. (098821031)
    Establishment
    Name Address ID/FEI Business Operations
    Mana Products 078870292 MANUFACTURE(57913-2900), LABEL(57913-2900), PACK(57913-2900)
    Close