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SOOTHE Regimen for Sensitive Skin Travel Size

Dosage form: kit
Ingredients: Allantoin 0.5g in 100mL, Dimethicone 2.9g in 100mL; Titanium Dioxide 2g in 100mL, Zinc Oxide 12g in 100mL
Labeler: Rodan & Fields
NDC Code: 14222-1015

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.

Gentle Cream Wash

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

Product Details

Directions

Use in the morning and evening. Prior to using, remove any facial makeup. Apply a thin, even layer over entire face, avoiding the eye area. For oily skin, rinse thoroughly and pat dry. For dry skin, remove with a fresh, dry gauze pad.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Cyclopentasiloxane, Propanediol, Isostearyl Alcohol, Aloe Barbadensis Leaf Juice, Ceramide NP, Ceramide EOP, Ceramide AP, Caffeine, Tocopheryl Acetate, Bisabolol, Butylene Glycol Cocoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Ethylcellulose, Aminomethyl Propanol, Sodium Lauroyl Lactylate, Tropolone, Phytosphingosine, Cholesterol, Carbomer, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Phenoxyethanol.

Sensitive Skin Treatment

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

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).

Questions

1-888-995-5656

Moisture Replenishing Cream

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

Product Details

Directions

Apply a generous dime-sized amount evenly over the entire face every morning and evening, avoiding the eye area. Use after SOOTHE Gentle Cream Wash and SOOTHE Sensitive Skin Treatment, and follow with SOOTHE Mineral Sunscreen in the morning.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Ingredients

Water/Aqua/Eau, Dimethicone, Glycerin, Pentylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Echium Plantagineum Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Olea Europaea (Olive) Fruit Oil, Vitis Vinifera (Grape) Seed Oil, Pichia Anomala Extract, Ascorbyl Palmitate, Tocopherol, Triacetin, Hydrogenated Lecithin, Carnitine, Canola Oil/Huile de colza, Urea, Lecithin, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Oleate, Glyceryl Stearate, Polysilicone-11, Sodium Hydroxide, Xanthan Gum, Citric Acid, BHT, Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Benzyl Alcohol, Phenoxyethanol.

Mineral Sunscreen Broad Spectrum SPF 30

+ Water Resistant (80 Minutes) 10 mL / 0.34 Fl. Oz. U.S.

Active Ingredients

Titanium Dioxide 2%

Zinc Oxide 12%

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:
    • after 80 minutes of swimming or sweating
    • 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 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

Cyclopentasiloxane, Water/Aqua/Eau, Cyclohexasiloxane, PEG-10 Dimethicone, Butylene Glycol, Dimethicone, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Glycerin, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Root Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Alumina, Disteardimonium Hectorite, Isoceteth-10, Methicone, Silica, Sodium Chloride, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Potassium Sorbate, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben.

Questions

1-888-995-5656

Principal Display Panel - Soothe Sensitive Skin Treatment Tube Label

RODAN+FIELDS®
SOOTHE™

2

Sensitive Skin Treatment

Traitement pour peau
sensible

Principal Display Panel - Reverse Broad Spectrum Sunscreen Label

RODAN+FIELDS®
SOOTHE™

4

Mineral Sunscreen
Broad Spectrum SPF 30

Ècran solaire minéral
large spectre FPS 30

Principal Display Panel - Soothe Regimen for Sensitive Skin Carton Label

RODAN+FIELDS

SOOTHE

Regimen for Sensitive Skin

Based on Multi-Med® Therapy, SOOTHE is a complete skincare system that uses clinically
tested cosmetic and OTC ingredients to defend against dry, chapped, sensitive skin, and to
soothe and calm visible facial redness.

This 4-product Regimen was developed by Stanford-trained Dermatologists Dr. Katie Rodan
and Dr. Kathy Fields.

RODAN+FIELDS®

Gentle Cream Wash

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

Sensitive Skin Treatment
Skin Protectant

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

Moisture Replenishing Cream

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

Mineral Sunscreen Broad Spectrum SPF 30
Water Resistant (80 Minutes)

10 mL / 0.34 Fl. Oz. U.S.

SOOTHE REGIMEN FOR SENSITIVE SKIN TRAVEL SIZE 
allantoin, dimethicone, titanium dioxide, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1015
Packaging
#Item CodePackage Description
1NDC:14222-1015-11 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 12 mL
Part 21 TUBE 10 mL
Part 1 of 2
SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (Allantoin) Allantoin0.5 g  in 100 mL
Dimethicone (Dimethicone) Dimethicone2.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Isododecane 
Rice Bran 
Chamomile 
Pelargonium Graveolens Flower Oil 
Lavender Oil 
Indian Frankincense 
Oligopeptide-10 
Tocopherol 
Tropolone 
Tranexamic Acid 
Honey 
Soybean Germ 
Perilla Frutescens Seed Oil 
Sunflower Oil 
Levomenol 
Angelica Sinensis Root 
Linoleic Acid 
Linolenic Acid 
Butylene Glycol 
Coco-Caprylate/Caprate 
Decyl Glucoside 
Hydrogenated Polybutene (1300 MW) 
PEG-40 Stearate 
Lecithin, Soybean 
Polyglyceryl-10 Stearate 
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) 
Xanthan Gum 
Hexylene Glycol 
Stannic Oxide 
1,2-Hexanediol 
Caprylyl Glycol 
Chlorhexidine Gluconate 
Chlorphenesin 
Phenoxyethanol 
Potassium Sorbate 
Sodium Benzoate 
.Beta.-Citronellol, (R)- 
Geraniol 
Linalool, (+/-)- 
Mica 
Titanium Dioxide 
Packaging
#Item CodePackage Description
112 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/24/2017
Part 2 of 2
MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide2 g  in 100 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 
Water 
Cyclomethicone 6 
PEG-10 Dimethicone (600 CST) 
Butylene Glycol 
Dimethicone 
Aluminum Starch Octenylsuccinate 
Caprylyl Trisiloxane 
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) 
Dipropylene Glycol 
Glycerin 
Green Tea Leaf 
Hyaluronate Sodium 
Glycyrrhiza Glabra 
Glycyrrhizinate Dipotassium 
Panthenol 
.Alpha.-Tocopherol Acetate 
Sodium Pyrrolidone Carboxylate 
Aluminum Oxide 
Disteardimonium Hectorite 
Isoceteth-10 
Methicone (20 CST) 
Silicon Dioxide 
Sodium Chloride 
Edetate Disodium Anhydrous 
Caprylyl Glycol 
Ethylhexylglycerin 
Potassium Sorbate 
Phenoxyethanol 
Methylparaben 
Ethylparaben 
Butylparaben 
Packaging
#Item CodePackage Description
110 mL in 1 TUBE
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 (051659584)

Revised: 07/2017
 
Rodan & Fields

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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