Label: UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide kit

  • 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 February 13, 2019

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

  • Gentle Exfoliating Acne Wash

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

    Drug Facts

  • Active Ingredient

    Salicylic Acid 0.5%

  • 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

    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.
    • Rinse right away with water if it gets in eyes.

    Stop and ask a doctor

    • If skin irritation occurs or gets worse.

    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, lather and rinse thoroughly.
    • 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, CocamidopropyI Betaine, Potassium Cocoyl Glycinate, Sodium Cocoyl Isethionate, Perlite, Lauryl Glucoside, Colloidal Sulfur, Glycerin, Potassium Cocoate, Cetyl Alcohol, Distearyl Phthalic Acid Amide, Hydrogenated Polyisobutene, Acrylates Copolymer, Propanediol, Myristic Acid, Sodium Chloride, Niacinamide, Coconut Acid, Lauric Acid, Sodium Isethionate, Fragrance (Parfum), Phytosteryl/OctyIdodecyl Lauroyl Glutamate, Xanthan Gum, Tocopherol, Dextrin, Polydextrose, AmyIopectin, Potassium Hydroxide, Propylene Glycol, Ethylhexylglycerin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol, Titanium Dioxide (Cl 77891), Red 33 (Cl 17200), Violet 2 (Cl 60725)

  • Dual Intensive Acne Treatment

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

    Drug Facts

  • Active Ingredients

    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

    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.
    • Rinse right away with water if it gets in eyes.
    • 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.

    Do not use if you

    • Have very sensitive skin.
    • Are sensitive to benzoyl peroxide.

    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 even 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.
  • Other Information

    Store between 15-30°C (59-86°F).

  • Inactive Ingredients

    Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MlPA-SuIfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, C13-14 Isoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool

  • Shine-Free Lotion Broad Spectrum SPF 20 Sunscreen

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 3%

    Zinc Oxide 14%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    For external use only

    When using this product

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • If rash occurs.

    • Do not use on damaged or broken skin.

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

    • Apply liberally at least 15 minutes before sun exposure and as needed avoiding the eye area.
    • Use a water-resistant sunscreen if swimming or sweating.
    • Reapply every two hours. 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 value 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.
    • For children under 6 months of age: ask a doctor.
  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Dimethicone, Butyloctyl Salicylate, PEG-10 Dimethicone, Pentylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butylene Glycol, Hexyl Laurate, Polysilicone-11, Tocopheryl Acetate, Boerhavia Diffusa Root Extract, Sodium PCA, Tetrahexyldecyl Ascorbate, PEG-60 Almond Glycerides, Nordihydraguaiaretic Acid, Cholesterol, Glycerin, Sorbitan Stearate, Oleanolic Acid, Polyglyceryl-4 Isostearate, Sorbitan Isostearate, Squalane, Stearic Acid, Fragrance, Alumina, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Methylcellulose Stearoxy Ether, Ammonium, Polyacryloyldimethyl Taurate, Polysorbate 20, Polysorbate 60, Polysorbate 80, Isohexadecane, Xanthan Gum, Disodium EDTA, Sodium Metabisulfite, Caprylyl Glycol, 1,2-Hexanediol, Chlorphenesin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol

  • Principal Display Panel - Kit Label

    RODAN+FIELDS

    UNBLEMISH

    Regimen for Adult Acne and Visible Signs of Aging

    Based on Multi-Med Therapy, UNBLEMISH is a complete skincare system for adult skin that combines cosmetics and active OTC ingredients to gently and effectively treat acne and aging concerns. Powerful ingredients penetrate pores where acne originates to quickly clear blemishes and prevent future breakouts while tackling visible signs of aging.

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

    RODAN+FIELDS

    Gentle Exfoliating Acne 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/
    2 x 0.76 Fl. Oz. U.S.

    Shine-Free Lotion
    Broad Spectrum SPF 20 Sunscreen

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

    Principal Display Panel - Kit Label
  • Principal Display Panel - Gentle Exfoliating Acne Wash Tube Label

    RODAN+FIELDS

    UNBLEMISH

    1 Gentle Exfoliating
    Acne Wash

    Principal Display Panel - Gentle Exfoliating Acne Wash Tube Label
  • Principal Display Panel - Dual Intensive Acne Treatment Tube Label

    RODAN+FIELDS

    UNBLEMISH

    3 Dual Intensive
    Acne Treatment

    Principal Display Panel - Dual Intensive Acne Treatment Tube Label
  • Principal Display Panel - Shine-Free Lotion Tube Label

    RODAN+FIELDS

    UNBLEMISH

    4 Shine-Free
    Lotion

    Broad Spectrum

    SPF 20 Sunscreen

    Principal Display Panel - Shine-Free Lotion Tube Label
  • INGREDIENTS AND APPEARANCE
    UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS 
    salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2100
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-2100-11 in 1 CARTON; Type 0: Not a Combination Product02/13/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 125 mL
    Part 21 BOTTLE, PUMP 45 mL
    Part 31 TUBE 30 mL
    Part 1 of 3
    UNBLEMISH GENTLE EXFOLIATING ACNE WASH 
    salicylic acid cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    PERLITE (UNII: 0SG101ZGK9)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SULFUR (UNII: 70FD1KFU70)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    AMYLOPECTIN (UNII: 4XO4QFV777)  
    COCONUT ACID (UNII: 40U37V505D)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GERANIOL (UNII: L837108USY)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 finalpart333D02/13/2019
    Part 2 of 3
    UNBLEMISH DUAL INTENSIVE ACNE TREATMENT 
    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 PEROXIDE0.025 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GERANIOL (UNII: L837108USY)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    145 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 finalpart333D02/13/2019
    Part 3 of 3
    UNBLEMISH SHINE FREE 
    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 DIOXIDE0.03 g  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.14 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (600000 CST) (UNII: RKI3S914RT)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 finalpart35202/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/13/2019
    Labeler - Rodan & Fields (051659584)