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Rejuvaderm Medispa Body (Ellen H Frankle MD Inc)

Available Formats

Dosage Form Package Information Links
LOTION 355 mL in 1 BOTTLE (51325-200-02) Label Information

Complete Rejuvaderm Medispa Body Information

  • ACTIVE INGREDIENT



    Active Ingredients     Purpose

    Octinoxate 7.5%          Sunscreen

    Octisalate 5.0%           Sunscreen

    Oxybenzone 3.0%      Sunscreen



  • INDICATIONS & USAGE



    Uses

    Helps prevent sunburn.

    Higher SPF gives more sunburn protection.

    Provides moderate protection against sunburn.


  • WARNINGS



    Warnings

    For external use only

    When using this product

    • keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if
    • rash or irritation develops and lasts.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT



    Inactive Ingredients Water (Aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150  Stearate, Polyacrylamide, Cetyl alcohol, Cetearyl Alcohol, Butyrospermum Parkii (shea butter), Cholesterol, Phenozyethanol,Dimethiconol, C13-14 Isoparaffin, Methylparaben, Xanathan gum, cetearyl glucoside, Disodium EDTA, Tocopheryl acetate, Laureth-7


  • DOSAGE & ADMINISTRATION



    Directions:

    • Apply daily to cleansed body skin or as directed by your physician; avoid face.
    • Apply generously before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    Other Information
    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and harmful effects of the sun.
    This product is not intended for sunbathing.

  • PRINCIPAL DISPLAY PANEL


    label




    Rejuvaderm Medispa
    Reawaken the essence that is you
    Body Lotion
    SPF 15
    12 fl oz (355 ml)
    401944skin
    www.riskindoc.com
    www.rejuvadermmedispa.com

  • INGREDIENTS AND APPEARANCE
    REJUVADERM MEDISPA BODY 
    octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51325-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 26.625 mL  in 355 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 17.75 mL  in 355 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 10.65 mL  in 355 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51325-200-02 355 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/01/2010
    Labeler - Ellen H Frankle MD Inc (603208240)