Label: PHELITYL DAY SPF 15- avobenzone and octinoxate 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

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  • Active Ingredients

    Avobenzone 2%, Octinoxate 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, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.

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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 - 90mL Jar Carton

    ERNO
    LASZLO

    NEW YORK

    PHELITYL

    DAY LOTION SPF 15

    90mL e 3.0 fl.oz.

    PRINCIPAL DISPLAY PANEL - 90mL Jar Carton
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  • INGREDIENTS AND APPEARANCE
    PHELITYL DAY SPF 15 
    avobenzone and octinoxate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2832
    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 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glyceryl Monostearate  
    Butylene Glycol  
    Cetyl Alcohol  
    Cyclomethicone 5  
    Alkyl (C12-15) Benzoate  
    Octyldodecyl Neopentanoate  
    Silicon Dioxide  
    Shea Butter  
    Emu Oil  
    Glycerin  
    PEG-100 Stearate  
    Myristyl Alcohol  
    Coco Glucoside  
    Ethylhexylglycerin  
    Dimethicone  
    Hydnocarpus Kurzii Seed Oil  
    Aloe Vera Leaf  
    Chamaemelum Nobile Flower  
    Green Tea Leaf  
    Asian Ginseng  
    Allantoin  
    Ceteth-20  
    Edetate Disodium  
    O-Cymen-5-Ol  
    Tetrahexyldecyl Ascorbate  
    .Alpha.-Tocopherol Acetate  
    Steareth-2  
    Steareth-20  
    Trolamine  
    Phenoxyethanol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57913-2832-9 1 in 1 CARTON
    1 90 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(57913-2832), LABEL(57913-2832), PACK(57913-2832)
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