Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
Rodan & Fields
Effective date
2017-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:43

Label at a glance#

ProductREDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness Travel Size
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure20 sections

Indications and 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.

Dosage and administration

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 fro...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Triple Defense Treatment

Broad Spectrum SPF 30 Sunscreen

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

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 2.5%

Octisalate 5%

Octocrylene 2.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

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

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Pore Minimizing Toner

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

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove. If irritation or rash occurs, discontinue use and consult your doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Questions

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel - Rodan Fields Redefine Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Carton Label
Principal Display Panel - Rodan Fields Redefine Carton Label

Principal Display Panel - Rodan Fields Redefine Triple Defense Treatment Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3

RODAN + FIELDS®

REDEFINE™

am

Triple Defense Treatment

Broad Spectrum SPF 30 Sunscreen

Traitement triple défense

écran solaire FPS 30 á large spectre

Principal Display Panel - Rodan Fields Redefine Triple Defense Treatment Label
Principal Display Panel - Rodan Fields Redefine Triple Defense Treatment Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2265-12021-04-01C16284748780-19d75b9d0-8d01-f424-e053-dadaa90a57cec1d96503-7d9f-4822-a174-e3209f972aec
14222-2265-12020-01-31C16284748780-19d75b9d0-8d01-f424-e053-dadaa90a57cec1d96503-7d9f-4822-a174-e3209f972aec

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-226514222-2265-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
011add30-8ac0-4071-ae2a-db889b648832c1d96503-7d9f-4822-a174-e3209f972aec2021-03-30WarningsExact identifier
spl set id: c1d96503-7d9f-4822-a174-e3209f972aec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.