FDA.reportPublic FDA data

SOOTHE Sensitive Skin Treatment

Manufacturer
Rodan & Fields
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:24

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

After cleansing, apply evenly to face until it blends into skin. Avoid eye area. Do not rinse. Use AM + PM. Reapply as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%, Dimethicone 2%

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 in 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

After cleansing, apply evenly to face until it blends into skin. Avoid eye area. Do not rinse. Use AM + PM. Reapply as needed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Annona Cherimola Fruit Extract, Aqua/Eau/Water, Ascorbic Acid, Benzoic Acid, Boswellia Serrata Extract, Butylene Glycol, Caprylyl Glycol, Chlorphenesin, Chlorphenesin, Citric Acid, Coco-Caprylate/Caprate, Decyl Glucoside, Dehydroacetic Acid, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Dipotassium Glycyrrhizate, Disodium Lauriminodipropionate Tocopheryl Phosphates, Glycerin, Glycyrrhetinic Acid, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Honey Extract/Mel Extract/Extrait De Miel, Hydrogenated Polyisobutene, Isododecane, Linoleic Acid, Linolenic Acid, Ocimum Sanctum Leaf Extract, Oleic Acid, Oligopeptide-10, Oryza Sativa (Rice) Bran Extract, Palmitic Acid, Panthenol, PEG-40 Stearate, Phenoxyethanol, Phenyl Trimethicone, Phenylpropanol, Phoenix Dactylifera (Date) Seed Extract, Phospholipids, Polyglyceryl-10 Stearate, Polysilicone-11, Propanediol, Sodium Acrylates Copolymer, Sodium Benzoate, Sodium Citrate, Sodium Dehydroacetate, Stearic Acid, Synthetic Fluorphlogopite, Tetrapeptide-16, Tin Oxide, Titanium Dioxide, Titanium Dioxide, Tocopherol, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel – 50 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

2

50 mL / 1.7 Fl. Oz U.S.

Principal Display Panel – 50 mL Carton Label
Principal Display Panel – 50 mL Carton Label

Principal Display Panel – 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

Skin Protectant Lotion

2

Principal Display Panel – 50 mL Bottle Label
Principal Display Panel – 50 mL Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2420-12022-12-27C16284748780-1e4f33bdf-ae8d-d8a0-e053-dadaa90a6e4eDrug Facts
14222-2420-12022-07-29C16284748780-1e4f33bdf-ae8d-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2420-1SOOTHE Sensitive Skin Treatment50 mL in 1 BOTTLELOTION504
14222-2420-1SOOTHE Sensitive Skin Treatment1 in 1 CARTONLOTION14
14222-2420-2SOOTHE Sensitive Skin Treatment1 in 1 CARTONLOTION14
14222-2420-2SOOTHE Sensitive Skin Treatment10 mL in 1 TUBELOTION104
14222-2420-3SOOTHE Sensitive Skin Treatment2 mL in 1 PACKETLOTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2420SOOTHE SENSITIVE SKIN TREATMENT (ALLANTOIN, DIMETHICONE) LOTION [RODAN & FIELDS]4Current NDC, Legacy NDC, 5 package rows20241213_2bd8cac4-5f40-4d04-91f2-3ea8a138033b.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-242014222-2420-1, 14222-2420-2, 14222-2420-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 49 matching rows.

Name, UNII, Kind table
NameUNIIKind
Allantoin344S277G0ZACTIB
Dimethicone92RU3N3Y1OACTIB
CHERIMOYA33WVT714QSIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZOIC ACID8SKN0B0MIMIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DEHYDROACETIC ACID2KAG279R6RIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES0K5Y9U1P6MIACT
GLYCERINPDC6A3C0OXIACT
ENOXOLONEP540XA09DRIACT
SUNFLOWER OIL3W1JG795YIIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HONEYY9H1V576FHIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
ISODODECANEA8289P68Y2IACT
LINOLEIC ACID9KJL21T0QJIACT
LINOLENIC ACID0RBV727H71IACT
HOLY BASIL LEAFSCJ765569PIACT
OLEIC ACID2UMI9U37CPIACT
OLIGOPEPTIDE-10Q46328TRNKIACT
RICE BRANR60QEP13ICIACT
PALMITIC ACID2V16EO95H1IACT
PANTHENOLWV9CM0O67ZIACT
PEG-40 STEARATEECU18C66Q7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PHENYLPROPANOL0F897O3O4MIACT
PHOENIX DACTYLIFERA SEED73NE6T0Q00IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

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
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
ndc (package): 14222-2420-2
ndc (package): 14222-2420-1
ndc (package): 14222-2420-3
ndc (product): 14222-2420
ndc11 (package): 14222242001
ndc11 (package): 14222242003
ndc11 (package): 14222242002
spl id: bbb80b31-6ecc-4d23-a2c3-784c6ea2289c
spl set id: 2bd8cac4-5f40-4d04-91f2-3ea8a138033b

Reported adverse events (FAERS/openFDA)#

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