UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS TRAVEL SIZE- sulfur, benzoyl peroxide, titanium dioxide, zinc oxide 
Rodan & Fields, LLC.

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.

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Acne Treatment Sulfur Wash

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

Drug Facts

Active Ingredient

Sulfur 3%

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
  • 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

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

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

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%

Zinc Oxide 4.75%

Purpose

Sunscreen

Uses

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

Other Information

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 Was

Traitement nettoyant au
soufre contre l'acné

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

Traitement intensif double action
contre l'acné

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

Lotion régulatrice Écran solaire
FPS 20+ à large spectre

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

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

Clarifying Toner

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

Dual Intensive Acne Treatment

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

Oil Control Lotion
Broad Spectrum SPF 20

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

Principal display Panel - Rodan Fields Unblemish Kit Label
UNBLEMISH REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS TRAVEL SIZE 
sulfur, benzoyl peroxide, titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2025
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-2025-11 in 1 CARTON; Type 0: Not a Combination Product07/24/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 22 BOTTLE, PUMP 8 mL
Part 31 TUBE 12 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
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 finalpart333D07/24/2017
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 Peroxide2.5 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
14 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 finalpart333D07/24/2017
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
112 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 finalpart35207/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/24/2017
Labeler - Rodan & Fields, LLC. (051659584)

Revised: 7/2017
Document Id: c161f48d-345d-4e36-bc4d-b616ffaf8aae
Set id: f2001803-be47-42a1-8509-57cd89b4a7d4
Version: 1
Effective Time: 20170724
 
Rodan & Fields, LLC.