RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]

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RODAN AND FIELDS UNBLEMISH (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BENTLEY LABORATORIES, LLC]
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NDC 54111-122-50
Set ID 2b3b6b62-364f-4aba-8024-3a73752b4c56
Category HUMAN OTC DRUG LABEL
Packager Bentley Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENTS:

    Titanium Dioxide 0.7%
    Zinc Oxide 4.75%

  • PURPOSE:

    Sunscreens

  • KEEP OUT OF REACH OF CHILDREN:

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

  • USES:

    Helps prevent sunburn.

  • 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 warm water to remove.

  • DIRECTIONS:

    Apply a generous dime-sized amount evenly over the entire face every morning, 15 minutes before sun exposure, as the final step in the Regimen. Reapply every 2 hours when exposed to the sun. Avoid the eye area.

  • INACTIVE INGREDIENTS:

    Water, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, PEG-10 Dimethicone, Butylene Glycol, Polysorbate 60, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Glyceryl Stearate, Caprylyl Glycol, Squalane, Citric Acid, Xanthan Gum, 1,2-Hexanediol, PEG-60 Almond Glycerides, Ceteth-10 Phosphate, Oleanolic Acid, Nordihydroguaiaretic Acid, Glycerin, Carbomer, Chlorphenesin, Dimethiconol, Dicetyl Phosphate, Cholesterol, Hexyl Laurate, Fragrance, Polyglyceryl-4 Isostearate, Potassium Sorbate, Sodium Benzoate, Tocopherol, Disodium EDTA, Tetrahexyldecyl Ascorbate, Azelaic Acid, Stearic Acid, Lecithin, Alumina, Sodium Chondroitin Sulfate, Atelocollagen, Boerhavia Diffusa Root Extract, Methylisothiazolinone, Tropolone

  • RODAN and FIELDS UNBLEMISHED Label

    RODAN and FIELDS UNBLEMISHED

    4 Oil Control Lotion

    BROAD SPECTRUM SPF 20 SUNSCREEN

    Manufactured for Rodan and Fields, LLC
    San Francisco, CA 94105
    Made in USA  UNSS030  85-07-0015
    Please recycle
    visit rodanandfields.com

    QUESTIONS OR COMMENTS
    1-888-995-5656

    30mL/1 Fl. Oz.

    RF_Unblemished

    RF_Unblemished1

  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS UNBLEMISH 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.21000 g  in 30 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.42500 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SQUALANE (UNII: GW89575KF9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    MASOPROCOL (UNII: 7BO8G1BYQU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-122-5030 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/05/2010
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-122)
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