JACK BLACK L.L.C.- avobenzone/homosalate/octisalate/petrolatum ointment

Jack Black L.L.C. by

Drug Labeling and Warnings

Jack Black L.L.C. 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

Warnings

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, Camellia Sinensis Leaf Extract.

Questions?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JACK BLACK L.L.C. 
avobenzone/homosalate/octisalate/petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40.2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-221-01	1 in 1 CARTON	10/01/2025
1	NDC: 66738-221-21	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(66738-221)