Label: UVA/UVB SPF 15 RODAN AND FIELDS- octinoxate, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 24, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients          Purpose

    Octinoxate 7.5%            Sunscreen

    Zinc Oxide 3.4%            Sunscreen


    Uses

    Helps prevent sunburn
    Higher SPF gives more sun protection
    Temporarily protects chapped or cracked skin.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

    when using this product keep out of eyes. Rinse with water to remove.

    Directions

    Apply a generous dime-sized amount evenly over entire face every morning

    Children under 6 months of age: ask a doctor.

    Reapply as needed or after towel drying, swimming, or sweating.

    Water, Octyldodecanol, Hydrogenated polydecene, butylene glycol, dimethicone, sodium dihydroxycetyl phosphate, glyceryl stearate, PEG-100 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, astrocaryum murumuru butter, Chamomilla recutita (matricaria) flower oil, Cucumis melo (melon) fruit extract, Persea Gratissima (avacado) oil, Cholesterol/Potassium sulfate, Acetyl glucosamine, squalene, Cholesterol, Linoleic acid, Bisabolol, Tocopheryl Acetate, Oleth-3 phosphate, propylene glycol dicaprylate ethylhexylglycerin, caprylyl glycol, triethoxycaprylylsilane, polysorbate 60, boron nitride, xanthan gum, tetrasodium EDTA, citric acid, potassium sorbate, phenoxyethanol



    image of box label


  • PRINCIPAL DISPLAY PANEL

    Rodan and Fields

    Soothe


    UVA/UVB SPF 15 Sunscreen


    50 mL/ 1.7 Fl. Oz.



    image of bottle





  • INGREDIENTS AND APPEARANCE
    UVA/UVB SPF 15   RODAN AND FIELDS
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CANTALOUPE (UNII: 8QF5D5H6UH)  
    SQUALENE (UNII: 7QWM220FJH)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2022-21 in 1 BOX
    1NDC:14222-2022-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/03/2011
    Labeler - Rodan & Fields LLC. (051659584)
    Registrant - Cosmetic Enterprises Ltd. (017701475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd.017701475manufacture
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