Label: R.E.M. DAY SPF 30- avobenzone, octinoxate and octisalate 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

    Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%

    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

    Water, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Beeswax, Bisabolol, Ethylhexylglycerin, Hydroxyethylcellulose, Lecithin, Micrococcus Lysate, Retinyl Palmitate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Corylus Avellana (Hazel) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Taraktogenos Kurzii Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Panax Ginseng Root Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Algae Extract, Plankton Extract, Sodium Hyaluronate, Sodium PCA, Steareth –20, Disodium EDTA, Phenoxyethanol, O-Cymen-5-Ol, Fragrance.

    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 - 90 mL Bottle Carton

    ERNO
    LASZLO

    NEW YORK

    R.E.M.

    DAY LOTION SPF 30

    90mL e 3.0 fl.oz.

    Principal Display Panel - 90 mL Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    R.E.M. DAY SPF 30 
    avobenzone, octinoxate, and octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57913-2834
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (Avobenzone) Avobenzone 30 mg  in 1 mL
    Octinoxate (Octinoxate) Octinoxate 75 mg  in 1 mL
    Octisalate (Octisalate) Octisalate 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Alkyl (C12-15) Benzoate  
    Octyldodecyl Neopentanoate  
    Butylene Glycol  
    Glycerin  
    Glyceryl Monostearate  
    PEG-100 Stearate  
    Yellow Wax  
    Levomenol  
    Ethylhexylglycerin  
    Vitamin A Palmitate  
    .Alpha.-Tocopherol Acetate  
    Tetrahexyldecyl Ascorbate  
    European Hazelnut Oil  
    Sunflower Oil  
    Avocado Oil  
    Sesame Oil  
    Hydnocarpus Kurzii Seed Oil  
    Jojoba Oil  
    Ginkgo  
    Aloe Vera Leaf  
    Asian Ginseng  
    Centella Asiatica  
    Echinacea Purpurea  
    Hyaluronate Sodium  
    Sodium Pyrrolidone Carboxylate  
    Steareth-20  
    Edetate Disodium  
    Phenoxyethanol  
    O-Cymen-5-Ol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57913-2834-9 1 in 1 CARTON
    1 90 mL in 1 BOTTLE
    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(57913-2834), LABEL(57913-2834), PACK(57913-2834)
    Close