Label: SOOTHE SENSITIVE SKIN TREATMENT- allantoin, dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 11, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Allantoin 0.5%, Dimethicone 2%

  • 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 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
  • INGREDIENTS AND APPEARANCE
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/09/2021
    Labeler - Rodan & Fields (051659584)