SOOTHE SENSITIVE SKIN TREATMENT- allantoin, dimethicone lotion 
Rodan & Fields

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Allantoin 0.5%, Dimethicone 2%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

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.

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

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

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?

1-888-995-5656

Principal Display Panel – 50 mL Carton Label

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 Bottle Label

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

Skin Protectant Lotion

2

Principal Display Panel – 50 mL Bottle Label
SOOTHE SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-2420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 g  in 100 mL
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CHERIMOYA (UNII: 33WVT714QS)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ENOXOLONE (UNII: P540XA09DR)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HONEY (UNII: Y9H1V576FH)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
ISODODECANE (UNII: A8289P68Y2)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
HOLY BASIL LEAF (UNII: SCJ765569P)  
OLEIC ACID (UNII: 2UMI9U37CP)  
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
RICE BRAN (UNII: R60QEP13IC)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
PHOENIX DACTYLIFERA SEED (UNII: 73NE6T0Q00)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-2420-11 in 1 CARTON03/09/2021
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:14222-2420-21 in 1 CARTON06/01/2021
210 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:14222-2420-32 mL in 1 PACKET; Type 0: Not a Combination Product04/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/09/2021
Labeler - Rodan & Fields (051659584)

Revised: 3/2021
Document Id: e5c3e6b2-c934-45e9-88e6-6b23423b0bcf
Set id: 2bd8cac4-5f40-4d04-91f2-3ea8a138033b
Version: 3
Effective Time: 20210311
 
Rodan & Fields