NDC 14222-2100 Unblemish Regimen For Acne, Blemishes And Breakouts

Salicylic Acid, Benzoyl Peroxide, Titanium Dioxide, Zinc Oxide

NDC Product Code 14222-2100

NDC Code: 14222-2100

Proprietary Name: Unblemish Regimen For Acne, Blemishes And Breakouts Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid, Benzoyl Peroxide, Titanium Dioxide, Zinc Oxide Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 14222 - Rodan & Fields
    • 14222-2100 - Unblemish Regimen For Acne, Blemishes And Breakouts

NDC 14222-2100-1

Package Description: 1 KIT in 1 CARTON * 1 TUBE in 1 CARTON > 30 mL in 1 TUBE * 1 BOTTLE, PUMP in 1 CARTON > 45 mL in 1 BOTTLE, PUMP * 1 TUBE in 1 CARTON > 125 mL in 1 TUBE

NDC Product Information

Unblemish Regimen For Acne, Blemishes And Breakouts with NDC 14222-2100 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Unblemish Regimen For Acne, Blemishes And Breakouts is salicylic acid, benzoyl peroxide, titanium dioxide, zinc oxide. The product's dosage form is kit and is administered via topical form.

Labeler Name: Rodan & Fields

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • 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)
  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rodan & Fields
Labeler Code: 14222
FDA Application Number: part333D Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-13-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Unblemish Regimen For Acne, Blemishes And Breakouts Product Label Images

Unblemish Regimen For Acne, Blemishes And Breakouts Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Gentle Exfoliating Acne Wash

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

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment

Acne treatment

Sunscreen
Sunscreen

Uses

  • For the treatment of acne.
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

  • For the treatment of acne.
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads.

  • Helps prevent sunburn.

Warnings

For external use only

  • 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.

For external use only

Otc - When Using

  • When using this productSkin 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.

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

Otc - Stop Use

  • Stop and ask a doctorIf skin irritation occurs or gets worse.

  • Stop use and ask a doctor ifIrritation becomes severe.

  • Stop use and ask a doctorIf rash occurs.

Otc - Keep Out Of Reach Of Children

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

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

  • 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.

  • 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.

  • 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.

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)

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

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

Dual Intensive Acne Treatment

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

Active Ingredients

Benzoyl Peroxide 2.5%

Titanium Dioxide 3%
Zinc Oxide 14%

Otc - Do Not Use

  • Do not use if youHave very sensitive skin.
  • Are sensitive to benzoyl peroxide.

  • Do not use on damaged or broken skin.

Other Information

Store between 15-30°C (59-86°F).

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

Shine-Free Lotion Broad Spectrum Spf 20 Sunscreen

Drug Facts

* Please review the disclaimer below.

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