UNBLEMISH REGIMEN FOR ACNE AND POST ACNE MARKS- sulfur, hydroquinone, titanium oxide, zinc oxide, benzoyl peroxide 
Rodan & Fields, LLC.

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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Unblemish - Regimen for Acne and Post Acne Marks

Active Ingredients                 Purpose

Sulfur 3 %                            Acne Treatment

Hydroquinone 2%               Skin Lightener

Benzoyl Peroxide 5%          Acne Treatment

Titanium Dioxide .7%           Sunscreen

Zinc Oxide 4.75%                Sunscreen

Acne Treatment Sulfur Wash

Uses

For the treatment of acne

Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads

Spot Fading Toner

Uses

For the gradual fading of dark spots and discolorations on the skin

Oil Control Lotion SPF 20 Sunscreen

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

Benzoyl Peroxide Lotion

Uses

For the treatment of acne.

Penetrates pores to control acne blemishes, pimples and blackheads

Helps prevent new acne blemishes, pimples and blackheads from forming

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

Acne Treatment Sulfur Wash

Do not get into eyes. If excessive skin irritation develops or increases discontinue use and consult a doctor

 

Spot Fading Toner

Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor

 

Oil Control Lotion SPF 20 Sunscreen

Stop use and ask a doctor if rash occurs

 

Benzoyl Peroxide Lotion

Stop use and ask a doctor if irritation becomes severe

Acne Treatment Sulfur Wash

  • For external use only

When using this product

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

  • Apply only to areas with acne

Do not use on

  • Broken Skin

  • Large areas of the skin

Spot Fading Toner

  • For external use only

When using this product

  • Avoid contact with eyes

  • Do not use on children under 12 years of age unless directed by a doctor

 

Oil Control Lotion SPF 20 Sunscreen

For external use only

  • Do no use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove

Benzoyl Peroxide Lotion

  • 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 are 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 combination.

Acne Treatment Sulfur Wash

Directions

Wet skin with lukewarm water. Using fingertips, gently and evenly massage a quarter-sized amount onto entire face for 30-60 seconds, avoiding contact with the eyes. Rinse thoroughly; pat dry. Use once daily and increase to twice daily as tolerated.

Spot Fading Toner

Directions

  • Apply evenly to the 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

  • Adults: apply a small amount as a thin layer on affected area once or twice daily, or use as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.

  • Sun exposure should be limited by using sunscreen or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring

  • Children under 12 year of age: do not use unless directed by a doctor.

Oil Control Lotion SPF 20 Sunscreen

Directions

  • Apply a dime-sized amount evenly over entire face, avoiding the eye area. Use every morning.

  • Apply liberally 15 minutes before sun exposure.

  • Use a water resistant sunscreen if swimming or sweating

  • Reapply at least every 2 hours

  • Immediately after towel drying.

  • At least every 2 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 10a.m. – 2p.m.

  • Wear long-sleeve shirts, pants, hats, and sunglasses

  • Children under 6 months of age ask a doctor.

Benzoyl Peroxide Lotion

Directions

  • Clean the skin thoroughly before applying this product.

  • Dispense 1-2 pumps from each side. Blend product and apply evenly over the entire face, avoiding the eye area. Allow to penetrate skin. Do not rinse off.

  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily as needed or as directed by a doctor. If bothersome dryness of peeling occur, reduce application to once a day or every other day and apply a moisturizer.

  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develop, stop use of both products and ask a doctor.

Acne Treatment Sulfur Wash

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Bisabolol, Blue 1 (CI 42090), Camellia Sinensis Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, C13-14 Isoparaffin, Diazolidinyl Urea, Diisodecyl Adipate, Distearyl Phthalic Acid Amide, Fragrance, Glycerin, Glyceryl Stearate, Hydrogenated Polyisobutene, Laureth-7, Lauryl Glucoside, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Polyacrylamide, Propylene Glycol, Propylparaben, Red 33 (CI 17200), Sodium Laureth Sulfate, Titanium Dioxide, Violet 2 (CI 60725), Water, Xanthan Gum

Spot Fading Toner

Alcohol, Arctostaphylos Uva Ursi Leaf Extract, Arnica Montana Flower Extract, Butylene Glycol, Caprylic/Capric Triglyceride, Citric Acid, Citrus Limon (Lemon) Fruit Extract, DMDM Hydantoin, Ethoxydiglycol, Foeniculum Vulgare (Fennel) Seed Extract, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Kojic Acid, Magnesium Ascorbyl Phosphate, Methylpropanediol, PEG-12 Dimethicone, Polysorbate 20, Propylene Glycol, Salicylic Acid, Sea Whip Extract, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Water, Yellow 5 (CI 19140), Yellow 6 (CI 15985), Zinc Phenolsulfonate

Oil Control Lotion SPF 20 Sunscreen

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

 

Benzoyl Peroxide Lotion

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Biosaccharide Gum-1, Carbomer, C13-14 Isoparaffin, Ceramide AP, Ceramide EOP, Ceramide NP, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Glycerin, Laureth-7, Niacinamide, Panthenol, Phytosphingosine, Polyacrylamide, Punica Granatum Extract, Purified Water, Sodium Lauroyl Lactylate, Xanthan Gum, Yucca Glauca Root Extract

Penetration-Enhancing Gel

Water, Ethoxydiglycol, PEG-7 Glyceryl Cocoate, Corn Starch Modified, Carbomer, Triethanolamine, BHT, Phenoxyethanol, Fragrance, Disodium EDTA, Ethylhexylglycerin

Rodan + Fields

UNBLEMISH

Regimen for Acne and Post Acne Marks

Acne Treatment Sulfur Wash     Spot Fading Toner           Dual Intesnsive Acne Treatment         Oil Control Lotion Broad Spectrum SPF 20 Sunscreen

 125 mL/4.2 Fl.OZ.                   125 mL/4.2 Fl.OZ.              2 x  22.5 mL/0.76 Fl.Oz.                                30 mL/1 Fl.Oz.

Box

UNBLEMISH REGIMEN FOR ACNE AND POST ACNE MARKS 
sulfur, hydroquinone, titanium oxide, zinc oxide, benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-5005
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5005-11 in 1 KIT08/21/201501/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 125 mL
Part 21 TUBE 125 mL
Part 31 TUBE 30 mL
Part 41 TUBE 22.5 mL
Part 1 of 4
ACNE SULFUR WASH 
sulfur cream
Product Information
Item Code (Source)NDC:14222-5006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 125 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIISODECYL ADIPATE (UNII: 3V0Q382O0P)  
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)  
LAURETH-7 (UNII: Z95S6G8201)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5006-21 in 1 BOX
1NDC:14222-5006-1125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D
Part 2 of 4
SPOT FADING TREATMENT 
hydroquinone cream
Product Information
Item Code (Source)NDC:14222-5007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 125 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LEMON (UNII: 24RS0A988O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
FENNEL SEED (UNII: G3QC02NIE6)  
GLYCERIN (UNII: PDC6A3C0OX)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
KOJIC ACID (UNII: 6K23F1TT52)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ZINC PHENOLSULFONATE (UNII: 4O71YT5YB5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5007-21 in 1 BOX
1NDC:14222-5007-1125 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A
Part 3 of 4
OIL CONTROL SPF 20 SUNSCREEN 
titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC:14222-5008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.7 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.75 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
AZELAIC ACID (UNII: F2VW3D43YT)  
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER 934 (UNII: Z135WT9208)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SQUALENE (UNII: 7QWM220FJH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROPOLONE (UNII: 7L6DL16P1T)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5008-21 in 1 BOX
1NDC:14222-5008-130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart352
Part 4 of 4
BENZOYL PEROXIDE 
benzoyl peroxide cream
Product Information
Item Code (Source)NDC:14222-5009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 22.5 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
CARBOMER 934 (UNII: Z135WT9208)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE EOP (UNII: 88KCS7120E)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHAMOMILE (UNII: FGL3685T2X)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-7 (UNII: Z95S6G8201)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-5009-21 in 1 BOX
1NDC:14222-5009-122.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/21/201501/01/2017
Labeler - Rodan & Fields, LLC. (051659584)

Revised: 8/2015
 
Rodan & Fields, LLC.