FDA.reportPublic FDA data

Avobenzone/Homosalate/Octisalate/Petrolatum

Manufacturer
Jack Black L.L.C. | Raining Rose
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:15

Label at a glance#

ProductJack Black L.L.C.
Active ingredientAVOBENZONE, PETROLATUM, OCTISALATE, HOMOSALATE
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

Warnings

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, Camellia Sinensis Leaf Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-221-01Jack Black L.L.C.1 in 1 CARTONOINTMENT11
66738-221-21Jack Black L.L.C.7 mL in 1 TUBEOINTMENT71

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-22166738-221-21, 66738-221-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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

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 L.L.C.AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.3e0eb291-6bda-2f26-e063-6294a90ac4662025-09-05WarningsExact identifier
ndc (package): 66738-221-01
ndc (package): 66738-221-21
ndc (product): 66738-221
ndc11 (package): 66738022101
ndc11 (package): 66738022121
spl id: 3e0eb291-6bdb-2f26-e063-6294a90ac466
spl set id: 3e0eb291-6bda-2f26-e063-6294a90ac466

Reported adverse events (FAERS/openFDA)#

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