Label: RODAN FIELDS SOOTHE 4 MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30


  • ACTIVE INGREDIENTS:

    Titanium Dioxide 2% Zinc Oxide 12%

  • PURPOSE

    Sunscreens

  • USES:

    To protect from sunburn and sun-induced skin irritations.

  • WARNINGS:

    For external use only.

    Do not use

    on damaged or broken skin.

    Stop use and ask a doctor

    If rash occurs.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Shake well before use. Apply a generous dime-sized amount evenly over the entire face every morning as the final step in the Regimen. Reapply every 2 - 3 hours as needed. Avoid the eye area. Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENTS:

    Alumina, Aluminum Starch Octenylsuccinate, Butylene Glycol, Camellia Sinesis Extract, Caprylyl Glycol, Caprylyl Methicone, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrolyzed Wheat Protein/PVP Crosspolymer, Methicone, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Silica, Sodium Chloride, Sodium Hyaluronate, Sodium PCA, Tocopheryl Acetate, Water

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • RODAN + FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 50ml (14222-0000-1)


    BottleLabel

    OuterLabel

  • INGREDIENTS AND APPEARANCE
    RODAN FIELDS SOOTHE 4 MINERAL SUNSCREEN BROAD SPECTRUM SPF 30  
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-0000-11 in 1 CARTON12/19/2017
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/03/2013
    Labeler - Rodan & Fields (051659584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.172198223manufacture(14222-0000)
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