Hydroquinone, Avobenzone, Homosalate, Octisalate, Octocrylene

Manufacturer
Rodan & Fields, LLC.
Effective date
2017-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:15:02

Label at a glance#

ProductREVERSE Lightening Regimen for the Appearance of Stubborn Dark Marks, Patches and Age Spots
Active ingredientHydroquinone, Avobenzone, Homosalate, Octisalate, Octocrylene
Label structure30 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 1...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Broad Spectrum SPF 50+ Sunscreen

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

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

Skin Lightening Treatment

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

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin lightener

Uses

INDICATIONS & USAGE SECTION

For the gradual fading of dark areas such as freckles, age and liver spots, or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

  • Adults: apply a small amount as a thin layer on affected area once or twice daily, or use as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent,or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reoccurring.
  • Children under 12 years of age: do not use unless directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Ethoxydiglycol, Cetearyl Alcohol, PPG-12/SMDI Copolymer, Diethylhexyl Sebacate, Polyacrylamide, Ceteareth-20, Glycerin, C13-14 Isoparaffin, Dimethicone, Fragrance/Parfum, Retinol, Ascorbyl Palmitate, Magnesium Ascorbyl Phosphate, Lactic Acid, Arctostaphylos Uva Ursi Leaf Extract, Sodium C14-16 Olefin Sulfonate, Sodium Metabisulfite, Laureth-7, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Citric Acid, Glycine Soja (Soybean) Oil, Propylene Glycol, Disodium EDTA, BHT, Methylparaben, Propylparaben, Benzoic Acid, Sorbic Acid, Chlorphenesin, Imidazolidinyl Urea, Phenoxyethanol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

SPL UNCLASSIFIED SECTION

Skin Lightening Toner

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

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin lightener

Uses

INDICATIONS & USAGE SECTION

For the gradual fading of dark areas such as freckles, age and liver spots, or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 a thin, even layer over the entire face, avoiding the eye area. Do not rinse off. Use twice daily. Apply as needed.

  • Adults: apply a small amount as a thin layer on affected area once or twice daily, or use as directed by a doctor. If no improvement is seen after three months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin.
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent,or protective clothing to cover bleached skin when using and after using the product in order to prevent darkening from reoccurring.
  • Children under 12 years of age: do not use unless directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Methylpropanediol, Alcohol, Polysorbate 20, Kojic Acid, Salicylic Acid, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi Leaf Extract, Arnica Montana Flower Extract, Citrus Limon (Lemon) Peel Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Sodium Sulfite, Fragrance/Parfum, PEG-12 Dimethicone, Zinc Phenolsulfonate, Citric Acid, Sodium Metabisulfite, Sodium Hydroxide, Propylene Glycol, Phenoxyethanol, Chlorphenesin, DMDM Hydantoin, Benzoic Acid, Sorbic Acid, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

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).

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Toner Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE

2 Skin Lightening
Toner

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Toner Label
Principal Display Panel - Rodan + Fields Reverse Skin Lightening Toner Label

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Treatment Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE

3 Skin Lightening
Treatment

Principal Display Panel - Rodan + Fields Reverse Skin Lightening Treatment Label
Principal Display Panel - Rodan + Fields Reverse Skin Lightening Treatment Label

Principal Display Panel - Rodan + Fields Reverse Broad Spectrum SPF 50+ Sunscreen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE

4 Broad Spectrum
SPF 50+ Sunscreen

Principal Display Panel - Rodan + Fields Reverse Broad Spectrum SPF 50+ Sunscreen Label
Principal Display Panel - Rodan + Fields Reverse Broad Spectrum SPF 50+ Sunscreen Label

Principal Display Panel - Rodan + Fields Reverse Lightening Regimen Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS®
REVERSE™

Regimen for the Appearance of Stubborn
Dark Marks, Patches and Age Spots

Based on Multi-Med® Therapy, the REVERSE Lightening
Regimen is a complete skincare system that combines
cosmetic and OTC ingredients to gradually lighten stubborn
dark marks, patches and excessive pigmentation. The highly
effective formulas contains 2% Hydroquinone to address
persistent discoloration for a more even, youthful complexion.

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

RODAN + FIELDS®

LIGHTENING

Deep Exfoliating Wash

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

Skin Lightening Toner

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

Skin Lightening Treatment

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

Broad Spectrum
SPF 50+ Sunscreen

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

Principal Display Panel - Rodan + Fields Reverse Lightening Regimen Carton Label
Principal Display Panel - Rodan + Fields Reverse Lightening Regimen Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-5030-12021-03-23C16284748780-19d75b9d0-8bde-f424-e053-dadaa90a57ce0fe2724c-ab9d-41f1-a4e5-bfd575e3d1f8
14222-5030-12020-01-31C16284748780-19d75b9d0-8bde-f424-e053-dadaa90a57ce0fe2724c-ab9d-41f1-a4e5-bfd575e3d1f8

Products#

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

DailyMed product names page 1 of 3 · 95 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-503014222-5030-1

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 116 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
fea9f1dd-1fb4-4de2-a916-2ead889a54ed0fe2724c-ab9d-41f1-a4e5-bfd575e3d1f82021-03-19WarningsExact identifier
spl set id: 0fe2724c-ab9d-41f1-a4e5-bfd575e3d1f8

Reported adverse events (FAERS/openFDA)#

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