SOOTHE REGIMEN FOR SENSITIVE SKIN- allantoin, dimethicone, titanium dioxide, zinc oxide kit

SOOTHE Regimen for Sensitive Skin by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Titanium Dioxide 2%

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.–2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months: Ask a doctor

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Cyclopentasiloxane, Water/Aqua/Eau, Cyclohexasiloxane, PEG-10 Dimethicone, Butylene Glycol, Dimethicone, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Glycerin, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Root Extract, Dipotassium Glycyrrhizate, Panthenol, Tocopheryl Acetate, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Alumina, Disteardimonium Hectorite, Isoceteth-10, Methicone, Silica, Sodium Chloride, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Potassium Sorbate, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben.

SPL UNCLASSIFIED SECTION

Sensitive Skin Treatment
50 mL/1.7 Fl. Oz. U.S.

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.

Other information

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

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).

SPL UNCLASSIFIED SECTION

Moisture Replenishing Cream
50 mL/1.7 Fl. Oz. U.S.

Product Details

Directions

Apply a generous dime-sized amount evenly over the entire face every morning and evening, avoiding the eye area. Use after SOOTHE Gentle Cream Wash and SOOTHE Sensitive Skin Treatment, and follow with SOOTHE Mineral Sunscreen in the morning.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Ingredients

Water/Aqua/Eau, Dimethicone, Glycerin, Pentylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Echium Plantagineum Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Olea Europaea (Olive) Fruit Oil, Vitis Vinifera (Grape) Seed Oil, Pichia Anomala Extract, Ascorbyl Palmitate, Tocopherol, Triacetin, Hydrogenated Lecithin, Carnitine, Canola Oil/Huile de colza, Urea, Lecithin, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Oleate, Glyceryl Stearate, Polysilicone-11, Sodium Hydroxide, Xanthan Gum, Citric Acid, BHT, Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Benzyl Alcohol, Phenoxyethanol.

SPL UNCLASSIFIED SECTION

Gentle Cream Wash
125 mL/4.2 Fl. Oz. U.S.

Product Details

Directions

Use in the morning and evening. Prior to using, remove any facial makeup. Apply a thin, even layer over entire face, avoiding the eye area. For oily skin, rinse thoroughly and pat dry. For dry skin, remove with a fresh, dry gauze pad.

Warnings

For external use only. When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Cyclopentasiloxane, Propanediol, Isostearyl Alcohol, Aloe Barbadensis Leaf Juice, Ceramide NP, Ceramide EOP, Ceramide AP, Caffeine, Tocopheryl Acetate, Bisabolol, Butylene Glycol Cocoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Ethylcellulose, Aminomethyl Propanol, Sodium Lauroyl Lactylate, Tropolone, Phytosphingosine, Cholesterol, Carbomer, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Phenoxyethanol.

Principal display Panel - Rodan Fields Soothe Sensitive Skin Treatment Label

RODAN + FIELDS®
SOOTHE

2 Sensitive Skin
Treatment

Principal display Panel - Rodan Fields Soothe Mineral Sunscreen Label

RODAN + FIELDS®
SOOTHE

4
Mineral Sunscreen

BROAD SPECTRUM SPF 30

Principal display Panel - Rodan Fields Soothe Carton Label

RODAN + FIELDS®
SOOTHE™

Regimen for Sensitive Skin

Based on Multi-Med® Therapy, SOOTHE is a complete skincare
system that uses clinically tested cosmetic and OTC ingredients
to defend against dry, chapped, sensitive skin, and to soothe and
calm visible facial redness.

This 4-product Regimen was developed by Stanford-trained
dermatologists Dr. Katie Rodan and Dr. Kathy Fields.

RODAN + FIELDS®

Gentle Cream Wash

125 mL/
4.2 Fl.Oz. U.S.

Sensitive Skin Treatment
Skin Protectant

50 mL/
1.7 Fl.Oz. U.S.

Moisture Replenishing Cream

50 mL/
1.7 Fl.Oz. U.S.

Mineral Sunscreen Broad Spectrum
SPF 30 Water Resistant (80 Minutes)

50 mL/
1.7 Fl.Oz. U.S.

INGREDIENTS AND APPEARANCE

SOOTHE REGIMEN FOR SENSITIVE SKIN 
allantoin, dimethicone, titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-1010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-1010-1	1 in 1 CARTON; Type 0: Not a Combination Product	06/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 TUBE	50 mL

Part 1 of 2

SENSITIVE SKIN TREATMENT 
allantoin, dimethicone lotion

Product Information
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	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2017

Part 2 of 2

MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	2 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Water (UNII: 059QF0KO0R)
Cyclomethicone 6 (UNII: XHK3U310BA)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dipropylene Glycol (UNII: E107L85C40)
Glycerin (UNII: PDC6A3C0OX)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Panthenol (UNII: WV9CM0O67Z)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Aluminum Oxide (UNII: LMI26O6933)
Disteardimonium Hectorite (UNII: X687XDK09L)
Isoceteth-10 (UNII: 1K92T9919H)
Methicone (20 CST) (UNII: 6777U11MKT)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Chloride (UNII: 451W47IQ8X)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Butylparaben (UNII: 3QPI1U3FV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2017

Labeler - Rodan & Fields (051659584)