Label: RODAN AND FIELDS UNBLEMISH- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 54111-122-50
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11, 2018

If you are a consumer or patient please visit this version.

  • 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)