FDA.reportPublic FDA data

Proactiv Solution Skin Lightening Lotion

Manufacturer
Guthy-Renker LLC
Effective date
2010-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:53:00

Label at a glance#

ProductProactiv Skin Lightening
Active ingredientHYDROQUINONE
Label structure9 sections

Dosage and administration

after cleansing, apply a thin layer on the affected areas, or as directed by a doctor discontinue use if no improvement is seen after three months of treatment

Storage and handling

keep away from eyes, lips and mouth avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product lightening effect of this product may not be noticeable when used on very dark skin this product may darken over time which is normal and does not affect the product performance

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Use

INDICATIONS & USAGE SECTION

works deep in the skin's surface to fade spots

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary sun exposure and use a sunscreen.
  • some users of this product may experience a mild skin irritation.
  • do not use on children under 12 years of age, unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe or gradual darkening of the skin occurs.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • after cleansing, apply a thin layer on the affected areas, or as directed by a doctor
  • discontinue use if no improvement is seen after three months of treatment

Other information

STORAGE AND HANDLING SECTION

  • keep away from eyes, lips and mouth
  • avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product
  • lightening effect of this product may not be noticeable when used on very dark skin
  • this product may darken over time which is normal and does not affect the product performance

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water (aqua), octyldodecanol, cyclopentasiloxane, hexylene glycol, glycolic acid, polyquaternium-37, propylene glycol dicaprylate/dicaprate, cyclohexasiloxane, cetearyl alcohol, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, glyceryl dilaurate, glyceryl stearate, PPG-1 trideceth-6, PEG-100 stearate, PEG-40 stearate, propylene glycol, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan & Fields

proactiv®
SOLUTION

SKIN
LIGHTENING
LOTION

helps to
fade discolorations
perfect for all skin types

1 FL. OZ. 30 mL

Principal Display Panel
Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11410-408-292020-01-29C16284748780-1956f9ecf-cfd2-621f-e053-dbdaa90a74adProactiv Solution Skin Lightening Lotion
11410-408-292019-10-21C16284748780-1956f9ecf-cfd2-621f-e053-dbdaa90a74adProactiv Solution Skin Lightening Lotion

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AE1
HYDROQUINONEACTIVE MOIETYXV74C1N1AE1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-40811410-408-29

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB

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
cf9dca83-cfdf-481a-9148-a68856529718863fd03d-5e44-4ea2-9ae4-1e89361aa9fb2010-06-21WarningsExact identifier
spl id: cf9dca83-cfdf-481a-9148-a68856529718
spl set id: 863fd03d-5e44-4ea2-9ae4-1e89361aa9fb

Reported adverse events (FAERS/openFDA)#

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