FDA.reportPublic FDA data

Jack Black

Manufacturer
Jack Black L.L.C. | Raining Rose
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:15

Label at a glance#

ProductJack Black
Active ingredientPETROLATUM, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

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.

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, Methyl Salicylate, Geranyl Acetate, Camellia Sinensis Leaf Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-161-01Jack Black1 in 1 CARTONOINTMENT12
66738-161-21Jack Black7 mL in 1 TUBEOINTMENT72

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-16166738-161-21, 66738-161-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
CETYL ALCOHOL936JST6JCNIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GERANYL ACETATE3W81YG7P9RIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
BEESWAX2ZA36H0S2VIACT
PETROLATUM4T6H12BN9UACTIB
POLYGLYCERYL-3 BEESWAXZ98M8HW9A6IACT
PERSEA GRATISSIMA (AVOCADO) OIL6VNO72PFC1IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
CERESINQ1LS2UJO3AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
METHYL SALICYLATELAV5U5022YIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT

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 BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3d5fafb9-62c9-ec69-e063-6394a90af8b92025-09-05WarningsExact identifier
ndc (package): 66738-161-21
ndc (package): 66738-161-01
ndc (product): 66738-161
ndc11 (package): 66738016101
ndc11 (package): 66738016121
spl id: 3e0f654a-4144-ef80-e063-6394a90acf6e
spl set id: 3d5fafb9-62c9-ec69-e063-6394a90af8b9

Reported adverse events (FAERS/openFDA)#

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