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

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  • Active Ingredients

    Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%

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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, 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.

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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 - 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
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  • INGREDIENTS AND APPEARANCE
    R.E.M. DAY SPF 30 
    avobenzone, octinoxate, and octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57913-2834
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Levomenol (UNII: 24WE03BX2T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    European Hazelnut Oil (UNII: 8RQ2839AVG)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Hydnocarpus Kurzii Seed Oil (UNII: N757YEZ18Q)  
    Jojoba Oil (UNII: 724GKU717M)  
    Ginkgo (UNII: 19FUJ2C58T)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Asian Ginseng (UNII: CUQ3A77YXI)  
    Centella Asiatica (UNII: 7M867G6T1U)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Steareth-20 (UNII: L0Q8IK9E08)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    O-Cymen-5-Ol (UNII: H41B6Q1I9L)  
    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)
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