UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS- salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide 
Rodan & Fields

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.

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Gentle Exfoliating Acne Wash

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

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment

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.

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

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

Warnings

For external use only

When using this product

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

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

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

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
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)

Revised: 2/2019
Document Id: 03b9e6b2-e824-479c-a5a7-51a8f27f2ad2
Set id: 7413c9a4-2e6e-492c-b998-ce25503e9502
Version: 1
Effective Time: 20190213
 
Rodan & Fields