REDEFINE REGIMEN FOR THE APPEARANCE OF LINES, PORES AND LOSS OF FIRMNESS TRAVEL SIZE- avobenzone, homosalate, octisalate, octocrylene lotion

REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness Travel Size by

Drug Labeling and Warnings

REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness Travel Size by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Triple Defense Treatment

Broad Spectrum SPF 30 Sunscreen

7 mL / 0.24 Fl. Oz. U.S.

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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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., and wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

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 Centre right away.

SPL UNCLASSIFIED SECTION

Daily Cleansing Mask

30 mL / 1.0 Fl. Oz. U.S.

Uses

For daily non-drying cleansing, gentle exfoliation, and skin smoothing.

Directions

Wet fingers and massage a thin, even layer of product over entire face, avoiding contact with the eyes. Allow product to dry, approximately 2 minutes. Rinse thoroughly with water and pat dry. Use morning and evening and follow with toner.

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.

Pore Minimizing Toner

30 mL / 1.0 Fl. Oz. U.S.

Uses

For gentle exfoliation and a minimzed apearance of pores. Prepares skin for the treatments that follow.

Directions

After cleansing apply evently to entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use morning and evening.

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.

SPL UNCLASSIFIED SECTION

Overnight Restorative Cream

7 mL / 0.24 Fl. Oz. U.S.

Uses

To replenish the skin's natural moisturizing factors for visibly firmer skin

Directions

Every evening, after cleansing and toning, apply a thin, even layer over the entire face, avoiding the eye area.

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.

Questions

1-888-995-5656

Principal Display Panel - Rodan Fields Redefine Carton Label

RODAN + FIELDS

REDEFINE

Regimen for the Appearance of 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 and more flawless-looking skin.

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

RODAN + FIELDS®

Daily Cleansing Mask

30 mL / 1.0 Fl. Oz. U.S.

Pore Minimizing Toner

30 mL / 1.0 Fl. Oz. U.S.

Triple Defense Treatment
Broad Spectrum SPF 30 Sunscreen

7 mL / 0.24 Fl. Oz. U.S.

Overnight Restorative Cream

7 mL / 0.24 Fl. Oz. U.S.

Principal Display Panel - Rodan Fields Redefine Triple Defense Treatment Label

3

RODAN + FIELDS®

REDEFINE™

am

Triple Defense Treatment

Broad Spectrum SPF 30 Sunscreen

Traitement triple défense

écran solaire FPS 30 á large spectre

INGREDIENTS AND APPEARANCE

REDEFINE REGIMEN FOR THE APPEARANCE OF LINES, PORES AND LOSS OF FIRMNESS TRAVEL SIZE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isododecane (UNII: A8289P68Y2)
Ethylhexyl Palmitate (UNII: 2865993309)
Polymethylsilsesquioxane (11 Microns) (UNII: Z570VEV8XK)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
PEG-100 Stearate (UNII: YD01N1999R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Tetrapeptide-21 (UNII: 179JUC43HU)
Dunaliella Salina (UNII: F4O1DKI9A6)
Bombyx Mori Fiber (UNII: 6LK42KUV6W)
Resveratrol (UNII: Q369O8926L)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Black Olive (UNII: 2M6QWV94OC)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Talc (UNII: 7SEV7J4R1U)
Sucrose Stearate (UNII: 274KW0O50M)
Polysorbate 20 (UNII: 7T1F30V5YH)
Polyisobutylene (1000 MW) (UNII: 5XB3A63Y52)
PEG-12 Dimethicone (UNII: ZEL54N6W95)
Hydrogenated Polydecene (550 MW) (UNII: U333RI6EB7)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Butylene Glycol (UNII: 3XUS85K0RA)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Propylparaben (UNII: Z8IX2SC1OH)
Isobutylparaben (UNII: 0QQJ25X58G)
Ferrous Oxide (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2265-1	1 in 1 BOX	07/24/2017
1		7 mL in 1 JAR; 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	07/24/2017

Labeler - Rodan & Fields (051659584)