FDA.reportPublic FDA data

HEMP LIP BALM

Manufacturer
Nemadji Management LLC | DIVERSIFIED MANUFACTURING CORP
Effective date
2019-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:00:01

Label at a glance#

ProductHEMP LIP BALM
Active ingredientOCTISALATE, OXYBENZONE
Label structure8 sections

Indications and uses

PREVENTS SUNBURN

Dosage and administration

APPLY TO AFFECTED AREA AS DESIRED.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTISALATE  7.3%

OXYBENZONE  4.7%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

WARNINGS

WARNINGS SECTION

EXTERNAL USE ONLY

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

USES

INDICATIONS & USAGE SECTION

PREVENTS SUNBURN

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY TO AFFECTED AREA AS DESIRED.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Hemp flower oil, Coconut oil, Beeswax, Patrolatum, Candelilla wax, Dimethicone, Aloe oil, Flavor, Tocopherol Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Hemp Lip Balm01b LBL_Hemp Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73278-201-112021-01-29C16284748780-1ba0f9c33-273d-a910-e053-dadaa90a0b85c6681e46-d615-4827-b4eb-4d2bccaba7d2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73278-201-11HEMP LIP BALM10 mL in 1 BOTTLELIPSTICK102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73278-201HEMP LIP BALM (OCTISALATE, OXYBENZONE) LIPSTICK [NEMADJI MANAGEMENT LLC]2Legacy NDC, 1 package rows20190808_c6681e46-d615-4827-b4eb-4d2bccaba7d2.zip

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
73278-20173278-201-11

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
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP8X454SZ22DIACT
COCONUT OILQ9L0O73W7LIACT
YELLOW WAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UIACT
CANDELILLA WAXWL0328HX19IACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
dd9b3ecb-84a7-452c-8e96-2d38b106f554c6681e46-d615-4827-b4eb-4d2bccaba7d22019-08-07WarningsExact identifier
spl id: dd9b3ecb-84a7-452c-8e96-2d38b106f554
spl set id: c6681e46-d615-4827-b4eb-4d2bccaba7d2

Reported adverse events (FAERS/openFDA)#

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