FDA.reportPublic FDA data

UNIQUE NATURAL PREMIUM SHEA BUTTER

Manufacturer
NATURAL COSMETICS INDUSTRY LTD
Effective date
2014-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:37:46

Label at a glance#

ProductUNIQUE NATURAL PREMIUM SHEA BUTTER
Active ingredientSHEA BUTTER
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT:

SHEA BUTTER 99.5%

OTC - PURPOSE SECTION

PURPOSE:

SKIN PROTECTANT​

INDICATIONS & USAGE SECTION

USES:

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO

  • ECZEMA
  • RASHES

WARNINGS SECTION

WARNING:

FOR EXTERNAL USE ONLY.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

CONDITION WORSENSSYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • APPLY AS NEEDED

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

  • FRAGRANCE (PARFUM)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DF Box_FragranceDF Box_Fragrance

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61515-101-132023-10-03C16284748780-19855e2a2-4a91-60a7-e053-dbdaa90a05bd52231956-e5e6-442c-9c44-689e1e3a3a88
61515-101-132019-11-27C16284748780-19855e2a2-4a91-60a7-e053-dbdaa90a05bd52231956-e5e6-442c-9c44-689e1e3a3a88

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SHEA BUTTERACTIVE INGREDIENTK49155WL9Y3
SHEA BUTTERACTIVE MOIETYK49155WL9Y3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P83

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61515-10161515-101-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YACTIB
TOCOPHEROLR0ZB2556P8IACT

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 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
06d4fa39-3b42-4894-e063-6294a90a6fa052231956-e5e6-442c-9c44-689e1e3a3a882023-10-03WarningsExact identifier
spl set id: 52231956-e5e6-442c-9c44-689e1e3a3a88

Reported adverse events (FAERS/openFDA)#

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