FDA.reportPublic FDA data

AFRICAN BLACK ACNE-PRONE FACE AND BODY BAR

Manufacturer
Sundial Group LLC
Effective date
2017-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:09

Label at a glance#

ProductAFRICAN BLACK ACNE-PRONE FACE AND BODY BAR
Active ingredientFUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Fucus Vesiculosus Extract (Tinc) - Reduces sebaceous excretions
Centella Asiatica Extract (Tinc) - Reduces mild skin inflammation
Melissa Officinalis Extract (Tinc) - Reduces irritation
Aloe Socotrina Extract (1X) - Anti bacterial

INDICATIONS & USAGE SECTION

Uses: Homeopathic facial cleansing bar for acne prone skin

WARNINGS SECTION

■ For external use only

WARNINGS SECTION

■ Avoid contact with eyes

OTC - PREGNANCY OR BREAST FEEDING SECTION

■ If pregnant or breastfeeding, ask a health professional before use.

OTC - ASK DOCTOR SECTION

■ If symptoms worsen or persist, consult a physician.

OTC - STOP USE SECTION

■ Discontinue use if skin rash develops..

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ■ Wet bar to create a lather and massage into face using circular motions. Rinse thoroughly.

SPL UNCLASSIFIED SECTION

Other information: For use on mild to moderate acne, or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Fragrance (Parfum), Carbon, Colloidal Oatmeal, Avena Sativa (Oat) Kernel Flour, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Gluconate, Butyrospermum Parkii (Shea) Butter*♥, Alcohol, Salix Alba (Willow) Bark Extract.

*Certified Organic Ingredient. ♥Fair Trade Ingredient

OTC - QUESTIONS SECTION

Questions? 631-842-8800 or visit NubianHeritage.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

USING GLOBALLY-SOURCED INGREDIENTS | SheaMoisture.com

External packagingExternal packaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58666-3413-72024-10-23C16284748780-1f386c64a-2f67-0266-e053-dadaa90a7c1aAFRICAN BLACK ACNE-PRONE FACE AND BODY BAR
58666-3413-72023-01-30C16284748780-1f386c64a-2f67-0266-e053-dadaa90a7c1aAFRICAN BLACK ACNE-PRONE FACE AND BODY BAR

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58666-341358666-3413-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PALM KERNELATE6H91L1NXTWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SHEA BUTTERK49155WL9YIACT
SALIX ALBA BARK205MXS71H7IACT
OATMEAL8PI54V663YIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
TEA TREE OILVIF565UC2GIACT
FUCUS VESICULOSUS535G2ABX9MACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
MELISSA OFFICINALISYF70189L0NACTIB
ALOEV5VD430YW9ACTIB
SODIUM GLUCONATER6Q3791S76IACT
SODIUM PALMATES0A6004K3ZIACT
ALCOHOL3K9958V90MIACT

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
2517d167-2d36-b77b-e063-6394a90ac1745fc5dbad-9812-050c-e053-2a91aa0ae7562024-10-22WarningsExact identifier
spl set id: 5fc5dbad-9812-050c-e053-2a91aa0ae756

Reported adverse events (FAERS/openFDA)#

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