Label: BEYOND THE SHAVE FOR MEN- sulfur, allantoin, dimethicone, avobenzone, homosalate, octisalate, octocrylene kit
- NDC Code(s): 14222-6000-1
- Packager: Rodan & Fields
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- UNBLEMISH Acne Treatment Sulfur Wash
- Active ingredients
- Purpose
- Uses
-
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.
- 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).
- SOOTHE Sensitive Skin Treatment
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
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
- Active Ingredients
- Purpose
-
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
-
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
-
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. OzSOOTHE
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 – Tube Label
- Principal Display Panel – Tube
- Principal Display Panel – Jar Label
-
INGREDIENTS AND APPEARANCE
BEYOND THE SHAVE FOR MEN
sulfur, allantoin, dimethicone, avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-6000 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-6000-1 1 in 1 CARTON; Type 0: Not a Combination Product 06/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 125 mL Part 2 1 TUBE 50 mL Part 3 1 JAR 30 mL Part 1 of 3 UNBLEMISH ACNE TREATMENT SULFUR WASH
sulfur creamProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 3.0 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 125 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2017 Part 2 of 3 SOOTHE SENSITIVE SKIN TREATMENT
allantoin, dimethicone lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 0.5 g in 100 mL Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 2.9 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2017 Part 3 of 3 REDEFINE TRIPLE DEFENSE TREATMENT SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3.0 g in 100 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 2.5 g in 100 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2017 Labeler - Rodan & Fields (051659584)