FDA.reportPublic FDA data

JB Intense Therapy Lip Balm SPF 25, Cherry Bourbon

Manufacturer
Jack Black L.L.C. | Raining Rose
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-02 01:04:09

Label at a glance#

ProductJack Black LLC
Active ingredientOCTISALATE, HOMOSALATE, AVOBENZONE, PETROLATUM
Label structure8 sections

Dosage and administration

• Apply liberally before sun exposure and reapply every 2 hours.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Petrolatum 40.2%

Purposes

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Skin protectant

Use

INDICATIONS & USAGE SECTION

• Helps protect against sunburn and chapped lips.

Warning

WARNINGS SECTION

Stop use if skin rash occurs.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally before sun exposure and reapply every 2 hours.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Butyloctyl Salicylate, Polypinene, Ethylhexyl Methoxycrylene, Hydrogenated Soybean Oil, Hydrogenated Coconut Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Synthetic Beeswax, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Lecithin, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Wax, Camellia Sinensis Leaf Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-04166738-041-21, 66738-041-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
PETROLATUM4T6H12BN9UACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
POLYGLYCERYL-3 BEESWAXZ98M8HW9A6IACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PERSEA GRATISSIMA (AVOCADO) OIL6VNO72PFC1IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
BEESWAX2ZA36H0S2VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
CETYL ALCOHOL936JST6JCNIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT

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
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsName fallback
generic name: OCTISALATE

Reported adverse events (FAERS/openFDA)#

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