Label: RODAN FIELDS UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- sulfur, benzoyl peroxide, titanium dioxide, zinc oxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 8, 2017

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

  • Acne Treatment Sulfur Wash

    30 mL / 1.0 Fl. Oz. U.S.

    Drug Facts

  • Active Ingredient

    Sulfure 3%

  • Purpose

    Acne treatment

  • Uses

    • the treatment of acne
    • Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads
  • Warnings

    For external use only

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
    • do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor

    Do not use on

    • broken skin
    • large areas of the skin

    When using this product

    • apply only to areas with acne

    Keep out of reach of children.

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

  • Directions

    • Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Inactive Ingredients

    Water/Aqua/Eau, Sodium Laureth Sulfate, Propylene Glycol, Distearyl Phthalic Acid Amide, Lauryl Glucoside, Aloe Barbadensis Leaf Juice, Diisodecyl Adipate, Glycerin, Hydrogenated Polyisobutene, Polyacrylamide, Cetearyl Alcohol, Titanium Dioxide (CI 77891), Arnica Montana Flower Extract, Camellia Sinensis Leaf Extract, Cetyl Alcohol, Magnesium Aluminum Silicate, Ceteareth-20, Laureth-7, PEG-100 Stearate, C13-14 Isoparaffin, Bisabolol, Glyceryl Stearate, Xanthan Gum, Fragrance/Parfum, Methylparaben, Glutaral, Chlorphenesin, Diazolidinyl Urea, Phenoxyethanol, Propylparaben, Citronellol, Geraniol, Limonene, Linalool, Violet 2 (CI 60725), Red 33 (CI 17200).

  • Questions

    1-888-995-5656

  • Clarifying Toner

    30 mL / 1.0 Fl. Oz. U.S.

    Product Details

    Directions

    Apply evenly to entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use once daily and increase to twice daily as tolerated.

  • Warnings

    For external use only. Do not swallow. If product is swallowed, get medical help or contact a Poison Control Centre right away. Keep entirely clear of eye area. If product enters eye, rinse with water. If irritation or rash occur, discontinue use and consult your doctor. Keep out of reach of children. Use only as directed. It is recommended that prior to exposure to the sun, users cover areas where alpha-hydroxy acids (AHAs) have been applied with sunscreen. Contact of the product with the skin must be of limited frequency and duration.

  • Ingredients

    Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Ethoxydiglycol, Aloe Barbadensis Leaf Juice, Glycolic Acid, Polysorbate 20, Alcohol, Sodium Hydroxide, Panthenol, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Leuconostoc/Radish Root Ferment Filtrate, Arginine, Niacinamide, Azelaic Acid, Menthyl Lactate, Atelocollagen, Zinc Phenosulfonate, Lecithin, PEG-12 Dimethicone, Benzophenone-9, Xanthan Gum, Sodium Chondrotin Sulfate, Fragrance/Parfum, Butylene Glycol, Propylene Glycol, Disodium EDTA, DMDM Hydantoin, Chlorphenesin, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Dual Intensive Acne Treatment

    2 x 4 mL / 0.13 Fl. Oz. U.S.

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne treatment

  • Uses

    • for the treatment of acne
    • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads
  • Warnings

    For external use only

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips, and mouth
    • avoid contact with hair and dyed fabrics, which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Stop use and ask a doctor if

    • irritation becomes severe

    Keep out of reach of children

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

  • Directions

    • Clean the skin thoroughly before applying this product
    • Dispense 1–2 pumps from each side. Blend product evenly
    • Cover the entire affected area with a thin layer one to three times daily
    • Do not rinse product off face
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
    • Wash hands after application to help avoid staining fabrics
  • Inactive Ingredients

    Water/Aqua/Eau, Ethoxydiglycol, Glycerin, Polyacrylamide, Allantoin, Niacinamide, Panthenol, Ceramide AP, Ceramide NP, Ceramide EOP, Punica Granatum Extract, Yucca Glauca Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Phytosphingosine, Cholesterol, Corn Starch Modified, C13-14 Isoparaffin, PEG-7 Glyceryl Cocoate, Disodium Oleamido MEA-Sulfosuccinate, Laureth-7, Sodium Lauroyl Lactylate, Sodium Sulfite, Xanthan Gum, Carbomer, Triethanolamine, Fragrance/Parfum, Disodium EDTA, BHT, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Benzyl Alcohol, Citronellol, Geraniol, Limonene, Linalool.

  • Questions

    1-888-995-5656

  • Oil Control Lotion Broad Spectrum SPF 20

    12 mL / 0.41 Fl. Oz. U.S.

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 0.7%

  • Purpose

    Sunscreen

    Zinc Oxide 4.75%

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on

    damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

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

  • Directions

    • Apply a generous amount evenly over the entire face every morning
    • Apply liberally 15 minutes before sun exposure
    • Reapply every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures.
      Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.–2 p.m.
      • wear long-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months: Ask a doctor
  • Other Information

    • Protect this product from excessive heat and direct sun
  • Inactive Ingredients

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

  • Questions

    1-888-995-5656

  • Principal display Panel - Rodan Fields Unblemish Acne Treatment Sulfur Wash Label

    RODAN + FIELDS®
    UNBLEMISH

    1 Acne Treatment
    Sulfur Wash

    Principal display Panel - Rodan Fields Unblemish Acne Treatment Sulfur Wash Label
  • Principal display Panel - Rodan Fields Unblemish Dual Intensive Acne Treatment Label

    RODAN + FIELDS®
    UNBLEMISH

    3 Dual Intensive
    Acne Treatment

    Principal display Panel - Rodan Fields Unblemish Dual Intensive Acne Treatment Label
  • Principal display Panel - Rodan Fields Unblemish Oil Control Lotion Label

    RODAN + FIELDS®
    UNBLEMISH

    4 Oil Control
    Lotion

    BROAD SPECTRUM SPF 20
    SUNSCREEN

    Principal display Panel - Rodan Fields Unblemish Oil Control Lotion Label
  • Principal display Panel - Rodan Fields Unblemish Kit Label

    RODAN + FIELDS®
    UNBLEMISH™

    Regiment for Acne, Blemishes and Breakouts

    Based on Multi-Med® Therapy, UNBLEMISH is a complete
    skincare system that combines cosmetic and active OTC
    ingredients that penetrate pores where acne originates,
    and helps prevent breakouts before they are visible on the
    skin's surface.

    This 4-product Regimen was developed by Stanford-trained
    dermatologists Dr. Katie Rodan and Dr. Kathy Fields.

    RODAN + FIELDS®

    Acne Treatment Sulfur Wash

    125 mL/
    4.2 Fl.Oz. U.S.

    Clarifying Toner

    125 mL/
    4.2 Fl.Oz. U.S.

    Dual Intensive Acne Treatment

    2 x 22.5 mL/
    0.76 Fl.Oz. U.S.

    Oil Control Lotion
    Broad Spectrum SPF 20

    30 mL/
    1 Fl.Oz. U.S.

    Principal display Panel - Rodan Fields Unblemish Kit Label
  • INGREDIENTS AND APPEARANCE
    RODAN FIELDS UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS 
    sulfur, benzoyl peroxide, titanium dioxide, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2020
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2020-11 in 1 CARTON; Type 0: Not a Combination Product06/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 125 mL
    Part 22 BOTTLE, PUMP 45 mL
    Part 31 TUBE 30 mL
    Part 1 of 3
    UNBLEMISH ACNE TREATMENT SULFUR WASH 
    sulfur cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur3.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Diisodecyl Adipate (UNII: 3V0Q382O0P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    Polyacrylamide (1500 MW) (UNII: 5D6TC4BRWV)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Laureth-7 (UNII: Z95S6G8201)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Levomenol (UNII: 24WE03BX2T)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Glutaral (UNII: T3C89M417N)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    .Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Limonene, (+)- (UNII: GFD7C86Q1W)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    D&C Violet No. 2 (UNII: 350KA7O6HK)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2017
    Part 2 of 3
    UNBLEMISH BENZOYL PEROXIDE 
    benzoyl peroxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyacrylamide (1500 MW) (UNII: 5D6TC4BRWV)  
    Allantoin (UNII: 344S277G0Z)  
    Niacinamide (UNII: 25X51I8RD4)  
    Panthenol (UNII: WV9CM0O67Z)  
    Ceramide AP (UNII: F1X8L2B00J)  
    Ceramide NP (UNII: 4370DF050B)  
    Ceramide 1 (UNII: 5THT33P7X7)  
    Punica Granatum Root Bark (UNII: CLV24I3T1D)  
    Yucca Glauca Root (UNII: 1A15YBH7N1)  
    Chamomile (UNII: FGL3685T2X)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Biosaccharide Gum-1 (UNII: BB4PU4V09H)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Modified Corn Starch (1-Octenyl Succinic Anhydride) (UNII: 461P5CJN6T)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    PEG-7 Glyceryl Cocoate (UNII: VNX7251543)  
    Disodium Oleamido MEA-Sulfosuccinate (UNII: 5M1101WGSY)  
    Laureth-7 (UNII: Z95S6G8201)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Sodium Sulfite (UNII: VTK01UQK3G)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carboxypolymethylene (UNII: 0A5MM307FC)  
    Trolamine (UNII: 9O3K93S3TK)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    .Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Limonene, (+)- (UNII: GFD7C86Q1W)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    122.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2017
    Part 3 of 3
    UNBLEMISH OIL CONTROL BROAD SPECTRUM SPF 20 
    titanium dioxide, zinc oxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.7 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Isododecane (UNII: A8289P68Y2)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Azelaic Acid (UNII: F2VW3D43YT)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Tocopherol (UNII: R0ZB2556P8)  
    Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
    Marine Collagen, Soluble (UNII: 8JC99XGU4W)  
    Nordihydroguaiaretic Acid, (+/-)- (UNII: 7PZ73W4ZNR)  
    Oleanolic Acid (UNII: 6SMK8R7TGJ)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Tropolone (UNII: 7L6DL16P1T)  
    PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Squalane (UNII: GW89575KF9)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Dimethiconol (70 CST) (UNII: MOT8IL21AR)  
    Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
    Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
    Hexyl Laurate (UNII: 4CG9F9W01Q)  
    Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)  
    Carboxypolymethylene (UNII: 0A5MM307FC)  
    Sodium Metabisulfite (UNII: 4VON5FNS3C)  
    Chondroitin Sulfate Sodium (Bovine) (UNII: 8QTV3DTT8W)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    .Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Limonene, (+)- (UNII: GFD7C86Q1W)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2017
    Labeler - Rodan & Fields, LLC. (051659584)