FDA.reportPublic FDA data

Proactiv Skin Purifying Mask

Manufacturer
The Proactiv Company, LLC | VEE PAK, LLC
Effective date
2017-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:23:37

Label at a glance#

ProductProactiv Skin Purifying Mask
Active ingredientSULFUR
Label structure10 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. apply a small amount to dampened skin. cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. because excessive drying of the skin may occur, start with one application daily, then gradually increas...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 6%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not use this product more than three times per day.
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

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.
  • apply a small amount to dampened skin.
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, tocopherol, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, tetrasodium EDTA, sodium sulfate, butylene glycol, phenoxyethanol, fragrance, titanium dioxide, zinc oxide, chromium hydroxide green

Questions or comments?

OTC - QUESTIONS SECTION

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

SKIN
PURIFYING
MASK

3 OZ. 85 g

sulfur acne medication

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-01511410-015-96, 11410-015-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
KAOLIN24H4NWX5COIACT
GLYCERETH-26NNE56F2N14IACT
LINOLEIC ACID9KJL21T0QJIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SYNTHETIC WAX (1800 MW)248P1AUJ90IACT
ZINC OXIDESOI2LOH54ZIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
LINOLENIC ACID0RBV727H71IACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
GERANIUM MACULATUM ROOT93IXI5B6OJIACT
TEA TREE OILVIF565UC2GIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDRATED SILICAY6O7T4G8P9IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHROMIUM HYDROXIDE GREENRV8FT8XF5RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM SULFATE0YPR65R21JIACT
EDETATE SODIUMMP1J8420LUIACT

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
424b577e-c780-4163-a6f0-bfa40fcd82e44bbaf325-16c2-44f1-a52d-baa86920d9bc2017-03-10WarningsExact identifier
spl id: 424b577e-c780-4163-a6f0-bfa40fcd82e4
spl set id: 4bbaf325-16c2-44f1-a52d-baa86920d9bc

Reported adverse events (FAERS/openFDA)#

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