JACK BLACK- avobenzone/homosalate/octisalate/petrolatum ointment

Jack Black by

Drug Labeling and Warnings

Jack Black by is a Otc medication manufactured, distributed, or labeled by Jack Black L.L.C., Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Purposes

Sunscreen

Sunscreen

Sunscreen

Skin protectant

Use

Helps protect against sunburn and chapped lips.

Warning

Stop use if skin rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Apply liberally before sun exposure and reapply every 2 hours.

Inactive ingredients

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.

Questions?

1-469-341-2700; 1-877-766-3388 www.getJackBlack.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JACK BLACK 
avobenzone/homosalate/octisalate/petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40.2 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETYL ALCOHOL (UNII: 936JST6JCN)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GERANYL ACETATE (UNII: 3W81YG7P9R)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
BEESWAX (UNII: 2ZA36H0S2V)
POLYGLYCERYL-3 BEESWAX (UNII: Z98M8HW9A6)
PERSEA GRATISSIMA (AVOCADO) OIL (UNII: 6VNO72PFC1)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
CERESIN (UNII: Q1LS2UJO3A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-161-01	1 in 1 CARTON	10/01/2025
1	NDC: 66738-161-21	7 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2025

Labeler - Jack Black L.L.C. (847024036)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	manufacture(66738-161)