Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2bd8cac4-5f40-4d04-91f2-3ea8a138033b
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g) Dimethicone (2 g)
Inactive Ingredients
Cherimoya Ascorbic Acid Benzoic Acid Indian Frankincense Butylene Glycol Caprylyl Glycol Chlorphenesin Citric Acid Monohydrate Coco-caprylate/caprate Decyl Glucoside Dehydroacetic Acid Glycyrrhizinate Dipotassium Disodium Lauriminodipropionate Tocopheryl Phosphates Glycerin Enoxolone Sunflower Oil Hexylene Glycol Honey Hydrogenated Polybutene (1300 Mw) Isododecane Linoleic Acid Linolenic Acid Holy Basil Leaf Oleic Acid Oligopeptide-10 Rice Bran Palmitic Acid Panthenol Peg-40 Stearate Phenoxyethanol Phenyl Trimethicone Phenylpropanol Phoenix Dactylifera Seed Lecithin, Soybean Polyglyceryl-10 Stearate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Propanediol Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Dehydroacetate Stearic Acid Magnesium Potassium Aluminosilicate Fluoride Stannic Oxide Titanium Dioxide Tocopherol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-09

Description

Allantoin 0.5%, Dimethicone 2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Allantoin 0.5%, Dimethicone 2%

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.

Directions

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

Questions?

1-888-995-5656

Do Not Use On
  • Deep or puncture wounds.
  • Animal bites.
  • Serious burns.
Active Ingredients

Allantoin 0.5%, Dimethicone 2%

Inactive Ingredients

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.

When Using This Product
  • Do not get in 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.
Keep Out of Reach of Children.

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

Principal Display Panel – 50 Ml Bottle Label

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

Skin Protectant Lotion

2

Principal Display Panel – 50 Ml Carton Label

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

2

50 mL / 1.7 Fl. Oz U.S.


Structured Label Content

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

Skin Protectant

Warnings

For external use only.

Directions

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

Questions?

1-888-995-5656

Do Not Use On (Do not use on)
  • Deep or puncture wounds.
  • Animal bites.
  • Serious burns.
Active Ingredients

Allantoin 0.5%, Dimethicone 2%

Inactive Ingredients (Inactive ingredients)

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.

When Using This Product (When using this product)
  • Do not get in eyes.
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • Condition worsens.
  • Symptoms last more than 7 days or clear up and occur again within a few days.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel – 50 Ml Bottle Label (Principal Display Panel – 50 mL Bottle Label)

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

Skin Protectant Lotion

2

Principal Display Panel – 50 Ml Carton Label (Principal Display Panel – 50 mL Carton Label)

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

2

50 mL / 1.7 Fl. Oz U.S.


Advanced Ingredient Data


Raw Label Data

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