OIL-CONTROL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]

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OIL-CONTROL DAY SPF 15 (AVOBENZONE AND OCTINOXATE) LOTION [ERNO LASZLO, INC.]
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NDC 57913-2857-8
Set ID 03301e1a-8d7c-4815-a95e-656b5ac7d049
Category HUMAN OTC DRUG LABEL
Packager Erno Laszlo, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 3.0%, Octinoxate 7.5%

  • Purpose

    Sunscreen

  • 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
  • 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 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
  • Inactive Ingredients

    Water, Butylene Glycol, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Saccharide Isomerate, Cetyl Alcohol, Octyldodecanol, Ceteth-20, Dimethicone, Squalane, Arachidyl Propionate, Ascorbic Acid/Orange/Citrus Limon/Citrus Aurantifolia Polypeptides, Ascorbic Acid Polypeptide, Beta-Glucan, Ethylhexylglycerin, Ethyl Linolenate, Retinyl Palmitate, Tocopheryl Acetate, Ethyl Oleate, Lecithin, Linolenic Acid, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceratonia Siliqua (Carob) Gum, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol, O-Cymen-5-Ol, Fragrance.

  • Other information

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

    Call toll free at 866-452-7956.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 90 mL Bottle Carton

    ERNO
    LASZLO

    NEW YORK

    OIL-CONTROL

    DAY LOTION SPF 15

    90mL e 3.0 fl.oz.

    Principal Display Panel - 90 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OIL-CONTROL DAY SPF 15 
    avobenzone and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2857
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETETH-20 (UNII: I835H2IHHX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYL LINOLENATE (UNII: T54Y8H042V)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYL OLEATE (UNII: Z2Z439864Y)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LOCUST BEAN GUM (UNII: V4716MY704)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57913-2857-81 in 1 CARTON
    190 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/10/2013
    Labeler - Erno Laszlo, Inc. (098821031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mana Products078870292MANUFACTURE(57913-2857) , LABEL(57913-2857) , PACK(57913-2857)
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