FDA.reportPublic FDA data

SOOTHE Sensitive Skin Treatment

Manufacturer
Rodan & Fields
Effective date
2017-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:58:26

Label at a glance#

ProductSOOTHE Sensitive Skin Treatment
Active ingredientAllantoin, Dimethicone
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

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.

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).

Other information

OTHER SAFETY INFORMATION

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

Principal Display Panel - Soothe Sensitive Skin Treatment Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS®
SOOTHE

2

Sensitive Skin
Treatment

Figure
Figure

Principal Display Panel - Soothe Sensitive Skin Treatment Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS®
SOOTHE

2

Sensitive
Skin
Treatment

RODAN+FIELDS®

Skin Protectant

50 mL/1.7 Fl. Oz.

Figure
Figure

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-1005-12020-12-30C16284748780-19d75b9d0-c72a-f424-e053-dadaa90a57ceDrug Facts
14222-1005-12020-01-31C16284748780-19d75b9d0-c72a-f424-e053-dadaa90a57ceDrug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-100514222-1005-0, 14222-1005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
IsododecaneA8289P68Y2IACT
Rice BranR60QEP13ICIACT
ChamomileFGL3685T2XIACT
Pelargonium Graveolens Flower Oil3K0J1S7QGCIACT
Lavender OilZBP1YXW0H8IACT
Indian Frankincense4PW41QCO2MIACT
Oligopeptide-10Q46328TRNKIACT
TocopherolR0ZB2556P8IACT
Tropolone7L6DL16P1TIACT
Tranexamic Acid6T84R30KC1IACT
HoneyY9H1V576FHIACT
Soybean GermJBW2VHD14MIACT
Perilla Frutescens Seed Oil322MS57V7ZIACT
Sunflower Oil3W1JG795YIIACT
Levomenol24WE03BX2TIACT
Angelica Sinensis RootB66F4574UGIACT
Linoleic Acid9KJL21T0QJIACT
Linolenic Acid0RBV727H71IACT
Butylene Glycol3XUS85K0RAIACT
Coco-Caprylate/Caprate8D9H4QU99HIACT
Decyl GlucosideZ17H97EA6YIACT
Hydrogenated Polybutene (1300 MW)7D1YQ9Y5EZIACT
PEG-40 StearateECU18C66Q7IACT
Lecithin, Soybean1DI56QDM62IACT
Polyglyceryl-10 Stearate90TF85HH91IACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)9E4CO0W6C5IACT
Xanthan GumTTV12P4NEEIACT
Hexylene GlycolKEH0A3F75JIACT
Stannic OxideKM7N50LOS6IACT
1,2-HexanediolTR046Y3K1GIACT
Caprylyl Glycol00YIU5438UIACT
Chlorhexidine GluconateMOR84MUD8EIACT
ChlorphenesinI670DAL4SZIACT
PhenoxyethanolHIE492ZZ3TIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium BenzoateOJ245FE5EUIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
35c66c30-8818-4178-b9f3-5ac06421a2da39522481-fb46-47a5-9fe3-daee98db12b82017-07-05WarningsExact identifier
spl set id: 39522481-fb46-47a5-9fe3-daee98db12b8

Reported adverse events (FAERS/openFDA)#

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