Label: BEYOND THE SHAVE FOR MEN- sulfur, allantoin, dimethicone, avobenzone, homosalate, octisalate, octocrylene kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated June 1, 2017

If you are a consumer or patient please visit this version.

  • UNBLEMISH Acne Treatment Sulfur Wash

    125 mL/4.2 Fl.Oz.

    Drug Facts

  • Active ingredients

    Sulfur 3%

  • Purpose

    Acne Treatment

  • Uses

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

    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.
    • Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
    • Apply only to areas with acne.

    Do not use on

    • Broken skin.
    • Large areas of the skin.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 eyes. Rinse thoroughly; pat dry. Use once daily and increase to twice daily as tolerated.

  • 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).

  • SOOTHE Sensitive Skin Treatment

    50 mL/1.7 Fl.Oz.

    Drug Facts

  • Active Ingredients

    Allantoin 0.5%

    Dimethicone 2.9%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin
    • Helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product

    • Do not get into eyes

    Stop use and ask doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

  • Other information

    Store between 15-30 ºC (59-86 ºF). Do not refrigerate.

  • Inactive ingredients

    Water/Aqua/Eau, Glycerin, Isododecane, Sodium Acrylates Copolymer, Oryza Sativa (Rice) Bran Extract, Chamomilla Recutita (Matricaria) Flower Extract, Pelargonium Graveolens Flower Oil, Lavandula Angustifolia (Lavender) Oil, Boswellia Serrata Extract, Oligopeptide-10, Tetrapeptide-16, Tocopherol, Tropolone, Tranexamic Acid, Honey Extract, Glycine Soja (Soybean) Germ Extract, Perilla Ocymoides Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Bisabolol, Angelica Polymorpha Sinensis Root Extract, Linoleic Acid, Linolenic Acid, Butylene Glycol, Coco-Caprylate/ Caprate, Decyl Glucoside, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Hydrogenated Polyisobutene, Lysolecithin, PEG-40 Stearate, Phospholipids, Polyglyceryl-10 Stearate, Polysilicone-11, Xanthan Gum, Hexylene Glycol, Tin Oxide, 1,2-Hexanediol, Caprylyl Glycol, Chlorhexidine Digluconate, Chlorphenesin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citronellol, Geraniol, Linalool, Mica, Titanium Dioxide (CI 77891).

  • REDEFINE Triple Defense Treatment SPF 30

    30 mL/1.0 Fl.Oz.

    Drug Facts

  • Active Ingredients

    Avobenzone 3%

    Homosalate 2.5%

    Octisalate 5%

    Octocrylene 2.7%

  • Purpose

    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
  • 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 doctor if rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • at least every 2 hours
      • use a water-resistant sunscreen if swimming or sweating
    • 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 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
    • Children under 6 months: Ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    Water/Aqua/Eau, Isododecane, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Glycerin, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Silica, Tetrapeptide-21, Dunaliella Salina Extract, Hydrolyzed Silk, Resveratrol, Sodium Hyaluronate, Humic Acids, Olea Europaea (Olive) Fruit Extract, Camellia Oleifera Leaf Extract, Talc, Sucrose Stearate, Polyurethane-40, Polysorbate 20, Polyisobutene, Polyacrylate-13, PEG-12 Dimethicone, Hydrogenated Polydecene, Fragrance/Parfum, Sorbitan Isostearate, Butylene Glycol, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Iron Oxides (CI 77491, CI 77492).

  • Principal Display Panel –Carton

    RODAN+FIELDS®

    BEYONND THE SHAVE™

    A smart approach to men's skincare to help relieve razor irritation
    and reveal better-looking skin.

    This three-product Regimen was curated by Stanford-trained
    dermatologists Dr. Katie Rodan and Dr. Kathy Fields to address
    a man's specific shaving needs.

    RODAN+FIELDS®

    FOR MEN

    SHAVE
    UNBLEMISH™ Acne Treatment
    Sulfur Wash
    125 mL /
    4.2 Fl. Oz

    SOOTHE
    SOOTHE™ Sensitive Skin
    Treatment
    50 mL /
    1.7 Fl. Oz.

    PROTECT

    REDEFINE™ Triple Defense Treatment
    Broad Spectrum SPF 30 Sunscreen
    30 mL /
    1.7 Fl. Oz.

    Principal Display Panel –Carton
  • Principal Display Panel – Tube Label

    RODAN+FIELDS®
    UNBLEMISHED

    1

    Acne Treatment

    Sulfur Wash

    Principal Display Panel – Tube Label
  • Principal Display Panel – Tube

    RODAN+FIELDS®
    SOOTHE

    2

    Sensitive Skin Treatment

    Principal Display Panel – Tube
  • Principal Display Panel – Jar Label

    RODAN+FIELDS®
    REDEFINE am

    3

    Triple Defense

    Treatment

    BROAD SPECTRUM SPF 30

    Principal Display Panel – Jar Label
  • INGREDIENTS AND APPEARANCE
    BEYOND THE SHAVE FOR MEN 
    sulfur, allantoin, dimethicone, avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-6000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-6000-11 in 1 CARTON; Type 0: Not a Combination Product06/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 125 mL
    Part 21 TUBE 50 mL
    Part 31 JAR 30 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
    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 finalpart333D06/01/2017
    Part 2 of 3
    SOOTHE SENSITIVE SKIN TREATMENT 
    allantoin, dimethicone lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 g  in 100 mL
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isododecane (UNII: A8289P68Y2)  
    Rice Bran (UNII: R60QEP13IC)  
    Chamomile (UNII: FGL3685T2X)  
    Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Indian Frankincense (UNII: 4PW41QCO2M)  
    Oligopeptide-10 (UNII: Q46328TRNK)  
    Tocopherol (UNII: R0ZB2556P8)  
    Tropolone (UNII: 7L6DL16P1T)  
    Tranexamic Acid (UNII: 6T84R30KC1)  
    Honey (UNII: Y9H1V576FH)  
    Soybean Germ (UNII: JBW2VHD14M)  
    Perilla Frutescens Seed Oil (UNII: 322MS57V7Z)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Levomenol (UNII: 24WE03BX2T)  
    Angelica Sinensis Root (UNII: B66F4574UG)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    Hydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Polyglyceryl-10 Stearate (UNII: 90TF85HH91)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Stannic Oxide (UNII: KM7N50LOS6)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorhexidine Gluconate (UNII: MOR84MUD8E)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    .Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
    Geraniol (UNII: L837108USY)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Mica (UNII: V8A1AW0880)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Part 3 of 3
    REDEFINE TRIPLE DEFENSE TREATMENT SPF 30 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3.0 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate2.5 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Polymethylsilsesquioxane (11 Microns) (UNII: Z570VEV8XK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Tetrapeptide-21 (UNII: 179JUC43HU)  
    Dunaliella Salina (UNII: F4O1DKI9A6)  
    Bombyx Mori Fiber (UNII: 6LK42KUV6W)  
    Resveratrol (UNII: Q369O8926L)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Black Olive (UNII: 2M6QWV94OC)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Talc (UNII: 7SEV7J4R1U)  
    Sucrose Stearate (UNII: 274KW0O50M)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Polyisobutylene (1000 MW) (UNII: 5XB3A63Y52)  
    PEG-12 Dimethicone (UNII: ZEL54N6W95)  
    Hydrogenated Polydecene (550 MW) (UNII: U333RI6EB7)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Ethylparaben (UNII: 14255EXE39)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Ferrous Oxide (UNII: G7036X8B5H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2017
    Labeler - Rodan & Fields (051659584)