FDA.reportPublic FDA data

Proactiv Skin Purifying Mask

Manufacturer
THE PROACTIV COMPANY LLC | Apex International Mfg LLC | VEE PAK, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:31:48

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, follows the directions stated below. clean the skin thoroughly before applying this product 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...

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

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness is 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 useon

  • broken skin
  • large areas of the skin

OTC - STOP USE SECTION

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, follows the directions stated below.
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer and rinse thoroughlyone 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, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, butylene glycol, phenoxyethanol, sodium sulfate, fragrance, titanium dioxide, zinc oxide, chromium hydroxide green

Questions or comments?

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign and
Domestic Components
Questions? 1-800-950-4695 • proactiv.com

Proactiv is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 1 OZ.  28 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®               

SKIN
PURIFYING
MASK                  

NET. WT. 1 OZ. (28 g)
sulfur acne medication

unit carton image
unit carton image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-013-00Proactiv Skin Purifying Mask1 in 1 BOXLOTION18
11410-013-00Proactiv Skin Purifying Mask30 g in 1 TUBELOTION308
11410-013-02Proactiv Skin Purifying Mask1 in 1 BOXLOTION18
11410-013-02Proactiv Skin Purifying Mask28 g in 1 TUBELOTION288
11410-013-05Proactiv Skin Purifying Mask1 in 1 BOXLOTION18
11410-013-05Proactiv Skin Purifying Mask85 g in 1 TUBELOTION858
11410-013-10Proactiv Skin Purifying Mask9 g in 1 TUBELOTION98
11410-013-10Proactiv Skin Purifying Mask1 in 1 BOXLOTION18

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-01311410-013-00, 11410-013-05, 11410-013-10, 11410-013-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
KAOLIN24H4NWX5COIACT
GLYCERETH-26NNE56F2N14IACT
LINOLEIC ACID9KJL21T0QJIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
LINOLENIC ACID0RBV727H71IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TEA TREE OILVIF565UC2GIACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
GERANIUM MACULATUM ROOT93IXI5B6OJIACT
HYDRATED SILICAY6O7T4G8P9IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
SODIUM SULFATE0YPR65R21JIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ZINC OXIDESOI2LOH54ZIACT
CHROMIUM HYDROXIDE GREENRV8FT8XF5RIACT
SULFUR70FD1KFU70ACTIB

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
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
ndc (package): 11410-013-10
ndc (package): 11410-013-02
ndc (package): 11410-013-00
ndc (package): 11410-013-05
ndc (product): 11410-013
ndc11 (package): 11410001305
ndc11 (package): 11410001300
ndc11 (package): 11410001310
ndc11 (package): 11410001302
spl id: 47d28c49-56d9-75a1-e063-6294a90a03c5
spl set id: 9f0eb12b-4da1-4498-9ffb-de8235264d9b

Reported adverse events (FAERS/openFDA)#

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