Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
Rodan & Fields
Effective date
2020-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:58:24

Label at a glance#

ProductREVERSE Regimen for the Appearance of Skin Dullness, Discoloration and Uneven Skin Tone
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure25 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 from ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF 50+ Sunscreen

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

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 doctor if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Caprylyl Methicone, Dipropylene Glycol, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Alcohol Denat., Methyl Glucose Sesquistearate, Potassium Cetyl Phosphate, Dipotassium Glycyrrhizate, Adenosine, Tocopheryl Acetate, Euterpe Oleracea Fruit Extract, Morus Alba Root Extract, Portulaca Oleracea Extract, Camellia Oleifera Leaf Extract, Dunaliella Salina Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyacrylate-15, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Palm Glycerides, Fragrance/Parfum, Isohexadecane, Panthenol, Butylene Glycol, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate-17, Polysorbate 80, Polydecene, C11-15 Pareth-40, C11-15 Pareth-7, Sorbitan Oleate, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate, Potassium Hydroxide, Disodium EDTA, Tetrasodium EDTA, Phenoxyethanol, Caprylyl Glycol, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool.

SPL UNCLASSIFIED SECTION

Deep Exfoliating Wash

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

Product Details

Directions

DOSAGE & ADMINISTRATION SECTION

Wet skin with lukewarm water. Using fingertips, gently and evenly massage a thin, even layer over the entire face for 30-60 seconds, avoiding contact with eyes. Rinse thoroughly with water and pat dry. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

WARNINGS SECTION

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, seek medical attention.

Ingredients

SPL UNCLASSIFIED SECTION

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Diethylhexyl Sebacate, Polylactic Acid, Cetearyl Alcohol, Jojoba Esters, PEG-40 Stearate, Glyceryl Stearate, Ammonium Laureth Sulfate, Magnesium Aluminum Silicate, Pentylene Glycol, Potassium Cetyl Phosphate, Ceteareth-20, Hydroxyacetophenone, Lactic Acid, Mentha Piperita (Peppermint) Oil, Fragrance/Parfum, Xanthan Gum, Glycolic Acid, Sodium Magnesium Silicate, Propylene Glycol, Citric Acid, Phenoxyethanol, Potassium Sorbate, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

SPL UNCLASSIFIED SECTION

Intensive Brightening Toner

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

Product Details

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly to entire face with a fresh gauze pad, avoiding the eye area. Do not rinse off. Allow to dry. Use morning and evening. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

WARNINGS SECTION

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, seek medical attention.

Ingredients

SPL UNCLASSIFIED SECTION

Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Polysorbate 20, Ethoxydiglycol, Alcohol, Kojic Acid, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Salicylic Acid, Phenylethyl Resorcinol, Tocopherol, Alanine, Glycine, Isoleucine, Leucine, Fragrance/Parfum, Sodium Sulfite, PEG-12 Dimethicone, Sodium Metabisulfite, Sodium Hydroxide, Citric Acid, Disodium EDTA, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool.

SPL UNCLASSIFIED SECTION

Dual Active Brightening Complex

2 x 25 mL/0.85 Fl. Oz. U.S.

Product Details

Directions

DOSAGE & ADMINISTRATION SECTION

After cleansing and toning, dispense an equal pea-sized amount of product from each tube, side by side. Blend product and apply evenly over the entire face, avoiding eye area. Allow product to be absorbed. Do not rinse off. Use once every other day for the first week and increase to twice daily as tolerated.

Warnings

WARNINGS SECTION

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, seek medical attention.

Other information

OTHER SAFETY INFORMATION

Store between 2-8 ºC (35-47 ºF)

Ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Vitamin C Formula: Isododecane, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethoxydiglycol, Ascorbic Acid, Caprylic/Capric Triglyceride, Kojic Acid, Ethylhexyl Hydroxystearate, Polysilicone-11, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Maltodextrin.

SPL UNCLASSIFIED SECTION

Retinol Formula: Water/Aqua/Eau, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Glycerin, Glyceryl Stearate, Ethoxydiglycol, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Stearic Acid, Polysorbate 60, Stearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Retinol, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Sorbitol, Tocopheryl Acetate, Fragrance/Parfum, Polysorbate 20, Carbomer, Triethanolamine, Glyceryl Acrylate/Acrylic Acid Copolymer, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, BHT, Citric Acid, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben, Citral, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140).

Principal Display Panel - Rodan Fields Reverse Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE™

Regiment for the Appearance of
Skin Dullness, Discoloration and
Uneven Skin Tone

Based on Multi-Med® Therapy, REVERSE Brightening Regimen is a
complete skincare system that combines cosmetic and OTC
ingredients to visibly brighten and even discolored skin. The
highly effective formulas contain Vitamin C and Retinol to provide
a long-term solution for a more radiant, even complexion.

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

RODAN + FIELDS®

BRIGHTENING

Deep Exfoliating Wash

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

Intensive Brightening Toner

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

Dual Active Brightening Complex

2 x 25 mL/
0.85 Fl.Oz. U.S.

Broad Spectrum
SPF 50+ Sunscreen

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

Principal Display Panel - Rodan Fields Reverse Carton Label
Principal Display Panel - Rodan Fields Reverse Carton Label

Principal Display Panel - Rodan Fields Reverse Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE

4 Broad Spectrum
SPF 50 + Sunscreen

Principal Display Panel - Rodan Fields Reverse Tube Label
Principal Display Panel - Rodan Fields Reverse Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-5020-12020-12-30C16284748780-19d75b9d0-8bdb-f424-e053-dadaa90a57ce2394249f-95a9-4d0b-adcf-367578a58fef
14222-5020-12020-01-31C16284748780-19d75b9d0-8bdb-f424-e053-dadaa90a57ce2394249f-95a9-4d0b-adcf-367578a58fef

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-502014222-5020-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Source Document#

Source XML · Source PDF

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
09892f55-10d6-4d5c-a893-9b5efcc2039f2394249f-95a9-4d0b-adcf-367578a58fef2021-03-30WarningsExact identifier
spl set id: 2394249f-95a9-4d0b-adcf-367578a58fef

Reported adverse events (FAERS/openFDA)#

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