FDA.reportPublic FDA data

Jack Black Intense Therapy Lip Balm Passion Fruit

Manufacturer
Jack Black, LLC | Swiss-American CDMO, LLC
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:38

Label at a glance#

ProductJack Black Intense Therapy Lip Balm Passion Fruit
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure9 sections

Indications and uses

Helps prevent sunburn and chapped lips.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Children under 6 months: ask a doctor.

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Stop use and ask doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

avobenzone   3.0%   sunscreen

octinoxate   7.5%   sunscreen

petrolatum   40.2%   skin protectant

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn and chapped lips.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn and chapped lips.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

theobroma cacao (coca) seed butter, lanolin, beeswax, ozokerite, polyglyceryl-3 beeswax, flavor, butyrospermum parkii (shea) butter, persea gratissima (avocado) oil, C18-38 alkyl hydroxystearol stearate, tocopheryl acetate, cyclopentasiloxane, microcrystalline wax, camellia sinenesis (green tea) leaf extract, cyclohexasiloxane

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Passion Fruit ArtworkPassion Fruit Artwork

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-065-25Jack Black Intense Therapy Lip Balm Passion Fruit7 g in 1 TUBEOINTMENT72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66738-065JACK BLACK INTENSE THERAPY LIP BALM PASSION FRUIT (AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN) OINTMENT [JACK BLACK, LLC]2Current NDC, Legacy NDC, 1 package rows20231109_f34beb68-e5dc-45c4-a6d1-e9a031016228.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-06566738-065-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PETROLATUM4T6H12BN9UACTIB
COCOA BUTTER512OYT1CRRIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CERESINQ1LS2UJO3AIACT
AVOCADO OIL6VNO72PFC1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOMETHICONE 50THT5PCI0RIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
CYCLOMETHICONE 6XHK3U310BAIACT

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
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
ndc (package): 66738-065-25
ndc (product): 66738-065
ndc11 (package): 66738006525
spl id: dccb6bb6-4b3a-444c-8d47-c04dcfb6765a
spl set id: f34beb68-e5dc-45c4-a6d1-e9a031016228

Reported adverse events (FAERS/openFDA)#

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