FDA.reportPublic FDA data

Vivant Sulfur Clay Mask

Manufacturer
Vivant Pharmaceuticals, LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:18

Label at a glance#

ProductVivant Sulfur Clay Mask
Active ingredientSULFUR
Label structure8 sections

Indications and uses

Uses ■ Helps clear up acne blemishes, blackheads or whiteheads and allows skin to heal

Dosage and administration

Directions ■ Cleanse the skin thoroughly before applying medication. Apply a generous layer of the mask to face avoiding the eye area. After fifteen minutes, wash off thoroughly. Follow with the recommended Vivant product. Since drying of the skin may occur, start with one application weekly; then gradually increase to two or three times weekly if needed or as directed by a doctor. If bothersome dryness or peeling...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Precipitated Sulfur, 10%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Uses ■ Helps clear up acne blemishes, blackheads or whiteheads and allows skin to heal

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product ■ Do not use on broken skin or apply to large areas of the
body.

OTC - STOP USE SECTION

Stop use and consult a doctor if

  • Rash or irritation develops and last

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
■ Cleanse the skin thoroughly before applying medication. Apply a generous layer of the mask to face avoiding the eye area. After fifteen minutes, wash off thoroughly. Follow with the recommended Vivant product. Since drying of the skin may occur, start with one application weekly; then gradually increase to two or three times weekly if needed or as directed by a doctor. If bothersome
dryness or peeling occurs, reduce application to once a week.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Kaolin, Talc, Bentonite, Magnesium Aluminum Silicate, Saccharomyces/Zinc Ferment, Ethylhexylglycerin, Phenoxyethanol

Questions

OTC - QUESTIONS SECTION

1-800-984-8268

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN2
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD2
1053330sulfur 10 % Medicated Liquid SoapSY2
1053330sulfur 10 % Topical MaskSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63750-006-04Vivant Sulfur Clay Mask118 mL in 1 JARPASTE1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63750-006VIVANT SULFUR CLAY MASK (SULFUR) PASTE [VIVANT PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20241107_10cd9db0-5388-b671-e063-6394a90af50d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63750-00663750-006-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SULFUR70FD1KFU70ACTIB
SACCHAROMYCES CEREVISIAE978D8U419HIACT
BENTONITEA3N5ZCN45CIACT
KAOLIN24H4NWX5COIACT
TALC7SEV7J4R1UIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
WATER059QF0KO0RIACT

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
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
ndc (package): 63750-006-04
ndc (product): 63750-006
ndc11 (package): 63750000604
spl id: 262ded33-a1b6-b4df-e063-6394a90a5893
spl set id: 10cd9db0-5388-b671-e063-6394a90af50d

Reported adverse events (FAERS/openFDA)#

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