SOOTHE SENSITIVE SKIN TREATMENT- allantoin, dimethicone lotion

SOOTHE Sensitive Skin Treatment by

Drug Labeling and Warnings

SOOTHE Sensitive Skin Treatment by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Bottle Label

RODAN+FIELDS

SOOTHE

Sensitive Skin Treatment

Skin Protectant Lotion

2

INGREDIENTS AND APPEARANCE

SOOTHE SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2420-1	1 in 1 CARTON	03/09/2021
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 14222-2420-2	1 in 1 CARTON	06/01/2021
2		10 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 14222-2420-3	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/09/2021

Labeler - Rodan & Fields (051659584)