RODAN AND FIELDS REDEFINE REGIMEN FOR THE APPEARANCE OF LINES, PORES AND LOSS OF FIRMNESS- octocrylene, avobenzone, octisalate, homosalate kit

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Avobenzone 3%

Homosalate 2.5%

Octisalate 5%

Octocrylene 2.7%
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 a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply a dime-sized amount evenly over entire face, avoiding the eye area. Use every morning and apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating
- Reapply 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
Inactive ingredients

Butylene Glycol, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Cetyl Alcohol, Chlorphenesin, Dimethicone, Dunaliella Salina Extract, Ethylhexyl Palmitate, Fragrance, Glycerin, Glyceryl Stearate, Humic Acids, Hydrogenated Polydecene, Hydrolyzed Silk, Iron Oxides, Isododecane, Olea Europaea (Olive) Fruit Extract, PEG-100 Stearate, PEG-12 Dimethicone, Phenoxyethanol, Polyacrylate-13, Polyisobutene,Polymethylsilsesquioxane, Polysorbate 20, Polyurethane-40, Resveratrol, Silica, Sodium Hyaluronate, Sucrose Stearate, Talc, Tetrapeptide-21, Water
Principal Display Panel - Kit Label

RODAN + FIELDS®
REDEFINE

Regimen for the Appearance
Lines, Pores and Loss of Firmness

Based on Multi-Med® Therapy, REDEFINE is a complete skincare
system that combines cosmetic and OTC ingredients to help
defend against and reduce the visible signs of aging for
noticeably firmer, smoother, flawless-looking skin.

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

RODAN + FIELDS®

Daily Cleansing Mask

125 mL/
4.2 Fl. Oz.

Pore Minimizing Toner

125 mL/
4.2 Fl. Oz.

Triple Defense Treatment
Broad Spectrum SPF 30 Sunscreen

30 mL/
1 Fl. Oz.

Overnight Restorative Cream

30 mL/
1 Fl. Oz.
Principal Display Panel - Jar Label

RODAN + FIELDS®
REDEFINE

3 Triple Defense
Treatment

am

BROAD SPECTRUM SPF 30

RODAN + FIELDS®
DERMATOLOGISTS

30 mL/1 Fl. Oz.

RODAN AND FIELDS REDEFINE REGIMEN FOR THE APPEARANCE OF LINES, PORES AND LOSS OF FIRMNESS
octocrylene, avobenzone, octisalate, homosalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2260

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 14222-2260-1	1 in 1 KIT; Type 0: Not a Combination Product	03/10/2016

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 JAR	30 mL
Part 2	1 TUBE	125 mL
Part 3	1 BOTTLE	125 mL
Part 4	1 JAR	30 mL

Part 1 of 4

RODAN AND FIELDS REDEFINE AM SPF 30
octisalate, avobenzone, octocrylene, homosalate cream

Product Information
Item Code (Source)	NDC: 14222-2250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3.0 g in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	2.5 g in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5.0 g in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Butylene Glycol (UNII: 3XUS85K0RA)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetyl Alcohol (UNII: 936JST6JCN)
Chlorphenesin (UNII: I670DAL4SZ)
Dimethicone (UNII: 92RU3N3Y1O)
Dunaliella Salina (UNII: F4O1DKI9A6)
Ethylhexyl Palmitate (UNII: 2865993309)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
Ferric Oxide Red (UNII: 1K09F3G675)
Isododecane (UNII: A8289P68Y2)
Black Olive (UNII: 2M6QWV94OC)
Peg-100 Stearate (UNII: YD01N1999R)
PEG-12 Dimethicone (300 CST) (UNII: ZEL54N6W95)
Phenoxyethanol (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Polysorbate 20 (UNII: 7T1F30V5YH)
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
Resveratrol (UNII: Q369O8926L)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Sucrose Stearate (UNII: 274KW0O50M)
Talc (UNII: 7SEV7J4R1U)
Tetrapeptide-21 (UNII: 179JUC43HU)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 14222-2250-1	30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2013

Part 2 of 4

REDEFINE DAILY CLEANSING MASK
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Kaolin (UNII: 24H4NWX5CO)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Isododecane (UNII: A8289P68Y2)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)
INGR	Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer (UNII: EX0F4CZ66H)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Bentonite (UNII: A3N5ZCN45C)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Peg-100 Stearate (UNII: YD01N1999R)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Oleth-10 Phosphate (UNII: Q95361F4VS)
INGR	Sodium Lactate (UNII: TU7HW0W0QT)
INGR	Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Potassium Hydroxide (UNII: WZH3C48M4T)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)
INGR	Edetate Disodium (UNII: 7FLD91C86K)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		125 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		11/16/2012

Part 3 of 4

REDEFINE PORE MINIMIZING TONER
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Lactobionic Acid (UNII: 65R938S4DV)
INGR	Gluconolactone (UNII: WQ29KQ9POT)
INGR	Deanol (UNII: 2N6K9DRA24)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
INGR	Ammonia (UNII: 5138Q19F1X)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Octoxynol-12 (UNII: 480KVF3EBY)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Lentil (UNII: 6O38V6B52O)
INGR	Carrageenan (UNII: 5C69YCD2YJ)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	Asian Ginseng (UNII: CUQ3A77YXI)
INGR	Glycyrrhiza Glabra (UNII: 2788Z9758H)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		125 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		11/16/2012

Part 4 of 4

REDEFINE OVERNIGHT RESTORATIVE CREAM
moisturizing cream

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Water (UNII: 059QF0KO0R)
INGR	Isododecane (UNII: A8289P68Y2)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Niacinamide (UNII: 25X51I8RD4)
INGR	Yellow Wax (UNII: 2ZA36H0S2V)
INGR	Gluconolactone (UNII: WQ29KQ9POT)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	PEG-100 Stearate (UNII: YD01N1999R)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Squalane (UNII: GW89575KF9)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
INGR	Sucrose Stearate (UNII: 274KW0O50M)
INGR	Cholesterol (UNII: 97C5T2UQ7J)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	Hydrolyzed Sericin (Enzymatic; 2500 MW) (UNII: 02EMA6F96C)
INGR	POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)
INGR	Soy Isoflavones (UNII: 71B37NR06D)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Tetrapeptide-21 (UNII: 179JUC43HU)
INGR	Vitamin A Palmitate (UNII: 1D1K0N0VVC)
INGR	Ascorbic Acid (UNII: PQ6CK8PD0R)
INGR	Hyaluronate Sodium (UNII: YSE9PPT4TH)
INGR	Black Olive (UNII: 2M6QWV94OC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		11/16/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/10/2016

Labeler - Rodan & Fields (051659584)

Name	Address	ID/FEI	Business Operations
Establishment
Northwest Cosmetic Labs		929572014	MANUFACTURE(14222-2250)

Name	Address	ID/FEI	Business Operations
Establishment
OHL		877844097	PACK(14222-2260)

RODAN AND FIELDS REDEFINE REGIMEN FOR THE APPEARANCE OF LINES, PORES AND LOSS OF FIRMNESS- octocrylene, avobenzone, octisalate, homosalate kit

Rodan and Fields REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness by

Drug Labeling and Warnings

Drug Details [pdf]