FDA.reportPublic FDA data

Acne Clearing Sulfur Mask

Manufacturer
AcneFree, LLC
Effective date
2026-07-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-04 03:32:48

Label at a glance#

ProductAcne Clearing Sulfur Mask
Active ingredientSULFUR
Label structure8 sections

Dosage and administration

gently massage into clean wet skin for two to three minutes until mask turns light blue leave on for an additional 10 minutes, until dry rinse off with warm water and pat dry if you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortable use 2-3 times per week, or as desired avoid the eye and lip areas

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 3.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

  • 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

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

  • gently massage into clean wet skin for two to three minutes until mask turns light blue
  • leave on for an additional 10 minutes, until dry
  • rinse off with warm water and pat dry
  • if you experience a tightening and cooling effect that you find too strong, rinse off the mask immediately if uncomfortable
  • use 2-3 times per week, or as desired
  • avoid the eye and lip areas

Other information

SPL UNCLASSIFIED SECTION

  • store at 59°–95° F (15°–35° C)
  • avoid product contact with silver jewelry, which may be discolored by this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia senegal gum, bentonite, butylene glycol, cellulose, copper gluconate, ethylhexylglycerin, hydroxypropyl methylcellulose, kaolin, magnesium aluminum silicate, magnesium aspartate, magnesium stearate, mannitol, methyl lactate, methylisothiazolinone, phenoxyethanol, sodium ascorbyl phosphate, sodium cocoyl isethionate, spirea ulmaria extract, tetrasodium EDTA, titanium dioxide, ultramarines, water, zinc gluconate, zinc PCA

Questions or comments?

OTC - QUESTIONS SECTION

1-888-768-2913

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelTubeTube

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850004234495GTIN-13: 0850004234495
EAN-13: 0850004234495
GTIN-12: 850004234495
UPC-A: 850004234495
GTIN storage (14 digits): 00850004234495		Label.jpg

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
80861-00180861-001-01

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
BUTYLENE GLYCOL3XUS85K0RAIACT
POWDERED CELLULOSESMD1X3XO9MIACT
COPPER GLUCONATERV823G6G67IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MAGNESIUM ASPARTATER17X820ROLIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
METHYL LACTATE, (-)-0379G9C44SIACT
ACACIA5C5403N26OIACT
BENTONITEA3N5ZCN45CIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
FILIPENDULA ULMARIA ROOT997724QNDSIACT
EDETATE SODIUMMP1J8420LUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ULTRAMARINE BLUEI39WR998BIIACT
WATER059QF0KO0RIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
ZINC PIDOLATEC32PQ86DH4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-07-24full-release2026-06-01 01:08:35

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
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
ndc (package): 80861-001-01
ndc (product): 80861-001
ndc11 (package): 80861000101
spl id: 57f46155-bc18-0a68-e063-6394a90a95da
spl set id: c0675282-ff00-edba-e053-2995a90ace68

Reported adverse events (FAERS/openFDA)#

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