FDA.reportPublic FDA data

SULFUR CALMING MASK

Manufacturer
CONTROL CORRECTIVE SKINCARE INC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:08

Label at a glance#

ProductSULFUR CALMING MASK
Active ingredientSULFUR
Label structure9 sections

Dosage and administration

Apply a thin layer with fingers to the entire affected areas. Leave on 5 to 10 minutes and then remove with a wet towel or sponge. Also may be used daily to spot treat acneic areas or left directly on blemishes overnight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SULFUR 10%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USE

INDICATIONS & USAGE SECTION

A THERAPEUTIC MASK WHICH ABSORBS EXCESS OIL AND CALMS INFLAMMED SKIN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. DO NOT USE ON BROKEN SKIN. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. DISCONTINUE USE IF IRRITATION BECOMES SEVERE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer with fingers to the entire affected areas. Leave on 5 to 10 minutes and then remove with a wet towel or sponge. Also may be used daily to spot treat acneic areas or left directly on blemishes overnight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, ALOE BARBADENSIS LEAF JUICE, KAOLIN, BENTONITE, GLYCERIN, PROPYLENE GLYCOL, ZINC OXIDE, TITANIUM DIOXIDE, MAGNESIUM ALUMINUM SILICATE, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, TRITICUM VULGARE (WHEAT) GERM OIL, SIMMONDSIA CHINENIS (JOJOBA) SEED OIL, CHAMOMILE RECUTITA (MATRICARIA) FLOWER EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, PHENOXYETHANOL, METHYLISOTHIAZOLINONE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Sulfur Calming Mask01b UC_Sulfur Calming Mask

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN5
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD5
1053330sulfur 10 % Medicated Liquid SoapSY5
1053330sulfur 10 % Topical MaskSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70764-103-522025-12-31C16284748780-12cef2736-6a93-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE - SULFUR CALMING MASK (70764-103)
70764-103-522025-01-30C16284748780-12cef2736-6a93-d83d-e063-dadaa90ab31fCONTROL CORRECTIVE - SULFUR CALMING MASK (70764-103)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70764-103-22SULFUR CALMING MASK57 g in 1 JARCREAM575
70764-103-52SULFUR CALMING MASK1 in 1 BOXCREAM15

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70764-10370764-103-22, 70764-103-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
KAOLIN24H4NWX5COIACT
BENTONITEA3N5ZCN45CIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ZINC OXIDESOI2LOH54ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
WHEAT GERM OIL14C97E680PIACT
JOJOBA OIL724GKU717MIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
EUCALYPTUS OIL2R04ONI662IACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
SULFUR CALMING MASKSULFURCONTROL CORRECTIVE SKINCARE INC446bd2ea-da88-422a-b086-e61b2d5b62692025-12-31WarningsExact identifier
ndc (package): 70764-103-22
ndc (package): 70764-103-52
ndc (product): 70764-103
ndc11 (package): 70764010352
ndc11 (package): 70764010322
spl id: 474bb0d3-4c59-f300-e063-6394a90a608a
spl set id: 446bd2ea-da88-422a-b086-e61b2d5b6269

Reported adverse events (FAERS/openFDA)#

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