FDA.reportPublic FDA data

Belli Acne Control Spot Treatment

Manufacturer
BODY HALO LLC | Chemolee Lab Corporation
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:53:59

Label at a glance#

ProductBelli Acne Control Spot Treatment
Active ingredientSULFUR
Label structure11 sections

Indications and uses

reduces the severity of acne blemishes helps prevent new acne blemishes

Dosage and administration

cleanse the skin thoroughly before applying medication cover the entire affected area with a thin layer one 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 physician if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Storage and handling

store below 77 degrees F / 25 degrees C

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Sulfur 3%

Purpose

OTC - PURPOSE SECTION

Anti-Acne Agent

Uses

INDICATIONS & USAGE SECTION

  • reduces the severity of acne blemishes
  • helps prevent new acne blemishes

Warnings

WARNINGS SECTION

For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes
  • rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or skin irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one 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 physician
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

STORAGE AND HANDLING SECTION

  • store below 77 degrees F / 25 degrees C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caprylyl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Ethylhexylglycerin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium PCA, Xanthan Gum

Belli Acne Control Spot Treatment 14.75ml (42281-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

InnerPackage
InnerPackage

OuterPackage
OuterPackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199632sulfur 3 % Topical CreamPSN8
199632sulfur 30 MG/ML Topical CreamSCD8
199632sulfur 3 % Topical CreamSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42281-001-002022-02-01C16284748780-19d75b9d0-d31b-f424-e053-dadaa90a57ceBODY HALO - Belli - Acne Control Spot Treatment (42281-001)
42281-001-002020-01-31C16284748780-19d75b9d0-d31b-f424-e053-dadaa90a57ceBODY HALO - Belli - Acne Control Spot Treatment (42281-001)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42281-001-00Belli Acne Control Spot Treatment1 in 1 CARTONCREAM18
42281-001-00Belli Acne Control Spot Treatment14.75 mL in 1 TUBECREAM14.758

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42281-001BELLI ACNE CONTROL SPOT TREATMENT (SULFUR) CREAM [BODY HALO LLC]8Current NDC, Legacy NDC, 2 package rows20250130_da979b69-1e4c-4e2b-82c3-0f155e978652.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU703
SULFURACTIVE MOIETY70FD1KFU703
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3
CUCUMBERINACTIVE INGREDIENTYY7C30VXJT3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ43
RADISHINACTIVE INGREDIENTEM5RP354633
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G3
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42281-00142281-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
RADISHEM5RP35463IACT
TEA TREE OILVIF565UC2GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
XANTHAN GUMTTV12P4NEEIACT
SULFUR70FD1KFU70ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates

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
Belli Acne Control Spot TreatmentSULFURBODY HALO LLCda979b69-1e4c-4e2b-82c3-0f155e9786522025-01-29WarningsExact identifier
ndc (package): 42281-001-00
ndc (product): 42281-001
ndc11 (package): 42281000100
spl id: 2cdcb7de-ce78-3d94-e063-6394a90a8bec
spl set id: da979b69-1e4c-4e2b-82c3-0f155e978652

Reported adverse events (FAERS/openFDA)#

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