Label: HYDRAPHEL DAY SPF15- avobenzone and octinoxate cream 

  • 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

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  • Active Ingredients

    Avobenzone 2%, Octinoxate 7.5%

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  • Purpose

    Sunscreen

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  • 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
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  • 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.

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  • 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
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  • Inactive Ingredients

    Water, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Polyisobutene, Glyceryl Stearate, PEG-100 Stearate, Glycerin Soja (Soybean) Oil, Hydrogenated Cottenseed Oil, Taraktogenos Kurzii Seed Oil, Polyglyceryl-4 Isostearate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Hydrogenated Olive Oil, Tocopheryl Acetate, Retinyl Palmitate, PEG-40 Castor Oil, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Disodium EDTA, Allantoin, Carbomer, Triethanolamine, Sodium Dehydroacetate, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol.

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  • Other information

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

    Call toll free at 866-452-7956.

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

    ERNO
    LASZLO

    NEW YORK

    HYDRAPHEL

    DAY CREAM SPF 15

    50mL e 1.7 fl.oz.

    Principal Display Panel - 50 mL Jar Carton
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  • INGREDIENTS AND APPEARANCE
    HYDRAPHEL DAY SPF15 
    avobenzone and octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2869
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (Avobenzone) Avobenzone 20 mg  in 1 mL
    Octinoxate (Octinoxate) Octinoxate 75 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Dimethicone  
    Cetostearyl Alcohol  
    Alkyl (C12-15) Benzoate  
    Glyceryl Monostearate  
    Soybean Oil  
    Hydrogenated Cottonseed Oil  
    Hydnocarpus Kurzii Seed Oil  
    Polyglyceryl-4 Isostearate  
    Hexyl Laurate  
    .Alpha.-Tocopherol Acetate  
    Vitamin A Palmitate  
    PEG-40 Castor Oil  
    Magnesium Ascorbyl Phosphate  
    Hyaluronate Sodium  
    Edetate Disodium  
    Allantoin  
    Trolamine  
    Sodium Dehydroacetate  
    Phenoxyethanol  
    Caprylyl Glycol  
    Hexylene Glycol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57913-2869-9 1 in 1 CARTON
    1 50 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(57913-2869), LABEL(57913-2869), PACK(57913-2869)
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