Octocrylene, Avobenzone, Octisalate, Homosalate

Manufacturer
Rodan & Fields | Northwest Cosmetic Labs | OHL
Effective date
2016-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:22:25

Label at a glance#

ProductRodan and Fields REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure9 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 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 1...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - Kit Label
Principal Display Panel - Kit Label

Principal Display Panel - Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REDEFINE

3 Triple Defense
Treatment

am

BROAD SPECTRUM SPF 30

RODAN + FIELDS®
DERMATOLOGISTS

30 mL/1 Fl. Oz.

Principal Display Panel - Jar Label
Principal Display Panel - Jar Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2260-12021-04-01C16284748780-19d75b9cf-de02-f424-e053-dadaa90a57ce343ba572-a72e-4469-9bc8-43def273ffb9
14222-2260-12020-01-31C16284748780-19d75b9cf-de02-f424-e053-dadaa90a57ce343ba572-a72e-4469-9bc8-43def273ffb9

Products#

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

DailyMed product names page 1 of 3 · 81 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-225014222-2250-1
14222-226014222-2260-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 109 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
980c4117-693b-4d11-9ce3-235e64ca50cd343ba572-a72e-4469-9bc8-43def273ffb92021-03-17WarningsExact identifier
spl set id: 343ba572-a72e-4469-9bc8-43def273ffb9

Reported adverse events (FAERS/openFDA)#

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