FDA.reportPublic FDA data

Proactiv Advanced Dark Spot Correcting Serum

Manufacturer
THE PROACTIV COMPANY LLC | KIK Holdco Company Inc
Effective date
2018-04-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:03:24

Label at a glance#

ProductProactiv Advanced Dark Spot Correcting Serum
Active ingredientHYDROQUINONE
Label structure11 sections

Dosage and administration

Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below. after thoroughly cleansing the skin, apply a thin layer to the affected area or as directed by a doctor. discontinue use if no improvement is seen after 3 months of treatment. keep away from eyes, lips and mouth. avoid product contact wit...

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

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
  • after thoroughly cleansing the skin, apply a thin layer to the affected area or as directed by a doctor.
  • discontinue use if no improvement is seen after 3 months of treatment.
  • 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.
  • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., PEG-40 hydrogenated castor oil, polysorbate 20, hippophae rhamnoides oil, hydroxyethylcellulose, sodium metabisulfite, sodium sulfite, disodium EDTA, citric acid, 1,2-hexanediol, caprylyl glycol, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ● Manufactured in Canada
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®                    

ADVANCED
DARK SPOT 
CORRECTING SERUM                

1 FL. OZ. 30 mL

hydroquinone skin lightener

Proactiv Dark Spot Correcting Serum 30 mL Carton
Proactiv Dark Spot Correcting Serum 30 mL Carton

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®  

ADVANCED
DARK SPOT 
CORRECTING SERUM  

0.33 FL.OZ. 10 mL

hydroquinone skin lightener

Proactiv Advanced Dark Spot Correcting Serum 10 mL Carton
Proactiv Advanced Dark Spot Correcting Serum 10 mL Carton

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-04511410-045-00, 11410-045-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
POLYSORBATE 207T1F30V5YHIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM SULFITEVTK01UQK3GIACT
EDETATE DISODIUM7FLD91C86KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
8956b3b2-1688-4c34-9c81-46f6e20d6f54be6e017f-5fbf-410d-98ed-8bf70702cb282018-04-12WarningsExact identifier
spl id: 8956b3b2-1688-4c34-9c81-46f6e20d6f54
spl set id: be6e017f-5fbf-410d-98ed-8bf70702cb28

Reported adverse events (FAERS/openFDA)#

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