FDA.reportPublic FDA data

SUFLUR SPOTandMASK Acne Clearing Treatment Mask

Manufacturer
CA-Botana International
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:57

Label at a glance#

ProductSUFLUR SPOTandMASK Acne Clearing Treatment Mask
Active ingredientSULFUR
Label structure9 sections

Indications and uses

Uses For the treatment of acne

Dosage and administration

Directions Apply an even layer onto clean skin Avoid eye area leave on for 10 minutes remove with damp washcloth and warm water for best results use at least once a week

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

OTC - PURPOSE SECTION

Active IngredientPurpose
Sulfur 5%Ace Treatment

Uses

INDICATIONS & USAGE SECTION

Uses

  • For the treatment of acne

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

OTC - DO NOT USE SECTION

Do not use on

  • Broken skin
  • Large areas of the skin

Sunburn Alert

OTHER SAFETY INFORMATION

Sunburn Alert: This product contains an Alpha Hydroxy Acid (AHA), increasing sun sensitivity and sunburn risk. Use sunscreen, wear protective clothing, and limit sun exposure during use and for a week after.

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

Directions

  • Apply an even layer onto clean skin
  • Avoid eye area
  • leave on for 10 minutes
  • remove with damp washcloth and warm water
  • for best results use at least once a week

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Kaolin, Glycerin, Lactic Acid, Glycolic Acid, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetyl Alcohol, Niacinamide, Sodium Hydroxide, Acacia Senegal Gum, Bentonite, Cetearyl Olivate, Xanthan Gum, Sodium Stearoyl Glutamate, Sorbitan Olivate, Caprylhydroxamic Acid, Hydrolyzed Gardenia Florida Extract, Aloe Barbadensis Leaf Juice, Cannabis Sativa Seed Oil, Lavandula Angustifolia, (Lavender) Oil, Vanilla Planifolia Fruit Extract, Zinc Oxide (CI 77947), Tocophryl Acetate, Glyceryl Caprylate, Triethyl Citrate, Maltodextrin, Sodium PCA, Citric Acid

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? clearstem.com

CLEARSTEM SULFUR SPOT&MASK - 1 fl oz 30 mL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEARSTEM

CLEAR PORE PROMISE

SULFUR

SPOT&MASK

Acne Clearing Treatment Mask

No Pore-Clogging Ingredients, Ever

CONGESTION +

BLEMISH PREVENTION

SULFUR 5%

1 fl oz 30 mL

ssmssm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291231sulfur 5 % Medicated Liquid SoapPSN1
1291231sulfur 50 MG/ML Medicated Liquid SoapSCD1
1291231sulfur 5 % Treatment MaskSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35192-200-00SUFLUR SPOTandMASK Acne Clearing Treatment Mask30 mL in 1 TUBECREAM301
35192-200-00SUFLUR SPOTandMASK Acne Clearing Treatment Mask1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-20035192-200-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTIC ACID33X04XA5ATIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
KAOLIN24H4NWX5COIACT
GLYCOLIC ACID0WT12SX38SIACT
SORBITAN OLIVATEMDL271E3GRIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CETYL ALCOHOL936JST6JCNIACT
NIACINAMIDE25X51I8RD4IACT
ACACIA SENEGAL GUM5C5403N26OIACT
CETEARYL OLIVATE58B69Q84JOIACT
VANILLA PLANIFOLIA FRUITQ74T35078HIACT
ZINC OXIDESOI2LOH54ZIACT
CITRIC ACID2968PHW8QPIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETEARYL ALCOHOL2DMT128M1SIACT
BENTONITEA3N5ZCN45CIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
GARDENIA JASMINOIDES FLOWER2TU49609L2IACT
MALTODEXTRIN7CVR7L4A2DIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SULFUR70FD1KFU70ACTIB
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
SODIUM PCA469OTG57A2IACT

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
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
ndc (package): 35192-200-00
ndc (product): 35192-200
ndc11 (package): 35192020000
spl id: 4d77310a-2442-a17e-e063-6394a90ae68b
spl set id: 4d77310a-2441-a17e-e063-6394a90ae68b

Reported adverse events (FAERS/openFDA)#

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