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 2.9%

Purpose

Skin protectant

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

When using this product

  • do not get into 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

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

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

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

Principal Display Panel - Soothe Sensitive Skin Treatment Tube Label

RODAN+FIELDS®
SOOTHE

2

Sensitive Skin
Treatment

Figure

Principal Display Panel - Soothe Sensitive Skin Treatment Carton Label

RODAN+FIELDS®
SOOTHE

2

Sensitive
Skin
Treatment

RODAN+FIELDS®

Skin Protectant

50 mL/1.7 Fl. Oz.

Figure
SOOTHE SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1005
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) Dimethicone2.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Isododecane (UNII: A8289P68Y2)  
Rice Bran (UNII: R60QEP13IC)  
Chamomile (UNII: FGL3685T2X)  
Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Indian Frankincense (UNII: 4PW41QCO2M)  
Oligopeptide-10 (UNII: Q46328TRNK)  
Tocopherol (UNII: R0ZB2556P8)  
Tropolone (UNII: 7L6DL16P1T)  
Tranexamic Acid (UNII: 6T84R30KC1)  
Honey (UNII: Y9H1V576FH)  
Soybean Germ (UNII: JBW2VHD14M)  
Perilla Frutescens Seed Oil (UNII: 322MS57V7Z)  
Sunflower Oil (UNII: 3W1JG795YI)  
Levomenol (UNII: 24WE03BX2T)  
Angelica Sinensis Root (UNII: B66F4574UG)  
Linoleic Acid (UNII: 9KJL21T0QJ)  
Linolenic Acid (UNII: 0RBV727H71)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
Decyl Glucoside (UNII: Z17H97EA6Y)  
Hydrogenated Polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PEG-40 Stearate (UNII: ECU18C66Q7)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Polyglyceryl-10 Stearate (UNII: 90TF85HH91)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Xanthan Gum (UNII: TTV12P4NEE)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Stannic Oxide (UNII: KM7N50LOS6)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Chlorhexidine Gluconate (UNII: MOR84MUD8E)  
Chlorphenesin (UNII: I670DAL4SZ)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)  
Geraniol (UNII: L837108USY)  
Linalool, (+/-)- (UNII: D81QY6I88E)  
Mica (UNII: V8A1AW0880)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1005-11 in 1 BOX06/01/201712/14/2021
1NDC:14222-1005-050 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/201712/14/2021
Labeler - Rodan & Fields (051659584)

Revised: 7/2017
Document Id: 35c66c30-8818-4178-b9f3-5ac06421a2da
Set id: 39522481-fb46-47a5-9fe3-daee98db12b8
Version: 3
Effective Time: 20170705
 
Rodan & Fields