SOOTHE Regimen for Sensitive Skin

Manufacturer
Rodan & Fields
Effective date
2020-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:22:23

Label at a glance#

ProductSOOTHE Regimen for Sensitive Skin
Active ingredientAllantoin, Dimethicone, Titanium Dioxide, Zinc Oxide
Label structure27 sections

Indications and 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

Dosage and administration

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, ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 2%

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Sensitive Skin Treatment
50 mL/1.7 Fl. Oz. U.S.

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Dimethicone 2.9%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

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

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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).

SPL UNCLASSIFIED SECTION

Moisture Replenishing Cream
50 mL/1.7 Fl. Oz. U.S.

Product Details

Directions

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Gentle Cream Wash
125 mL/4.2 Fl. Oz. U.S.

Product Details

Directions

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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.

Principal Display Panel - Rodan Fields Soothe Sensitive Skin Treatment Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
SOOTHE

2 Sensitive Skin
Treatment

Principal Display Panel - Rodan Fields Soothe Sensitive Skin Treatment Label
Principal Display Panel - Rodan Fields Soothe Sensitive Skin Treatment Label

Principal Display Panel - Rodan Fields Soothe Mineral Sunscreen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
SOOTHE

4
Mineral Sunscreen

BROAD SPECTRUM SPF 30

Principal Display Panel - Rodan Fields Soothe Mineral Sunscreen Label
Principal Display Panel - Rodan Fields Soothe Mineral Sunscreen Label

Principal Display Panel - Rodan Fields Soothe Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

Sensitive Skin Treatment
Skin Protectant

50 mL/
1.7 Fl.Oz. U.S.

Moisture Replenishing Cream

50 mL/
1.7 Fl.Oz. U.S.

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

50 mL/
1.7 Fl.Oz. U.S.

Principal Display Panel - Rodan Fields Soothe Carton Label
Principal Display Panel - Rodan Fields Soothe Carton Label

FDA-Initiated Inactive NDC Indexing#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-101014222-1010-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 79 matching rows.

Source Document#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bd19d970-c06e-463c-9602-079e0f9b2a465b28433d-4b45-456c-a1b0-e2fdf2532bfd2020-12-29WarningsExact identifier
spl id: bd19d970-c06e-463c-9602-079e0f9b2a46
spl set id: 5b28433d-4b45-456c-a1b0-e2fdf2532bfd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.