UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide kit
UNBLEMISH Regimen for Acne, Blemishes and Breakouts by
Drug Labeling and Warnings
UNBLEMISH Regimen for Acne, Blemishes and Breakouts by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Gentle Exfoliating Acne Wash
- Active Ingredient
- Purpose
- Uses
- Warnings
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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.
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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
- Active Ingredients
- Purpose
- Uses
-
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.
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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
-
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
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
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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
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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 Sunscreen30 mL/
1.0 Fl. Oz. U.S. - Principal Display Panel - Gentle Exfoliating Acne Wash Tube Label
- Principal Display Panel - Dual Intensive Acne Treatment Tube Label
- Principal Display Panel - Shine-Free Lotion Tube Label
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INGREDIENTS AND APPEARANCE
UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS
salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 14222-2100 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14222-2100-1 1 in 1 CARTON; Type 0: Not a Combination Product 02/13/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 125 mL Part 2 1 BOTTLE, PUMP 45 mL Part 3 1 TUBE 30 mL Part 1 of 3 UNBLEMISH GENTLE EXFOLIATING ACNE WASH
salicylic acid creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 125 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Part 2 of 3 UNBLEMISH DUAL INTENSIVE ACNE TREATMENT
benzoyl peroxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Part 3 of 3 UNBLEMISH SHINE FREE
titanium dioxide, zinc oxide lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.03 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.14 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Labeler - Rodan & Fields (051659584)
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