JACK BLACK- avobenzone/homosalate/octisalate/petrolatum ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

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, 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: 66738-861
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-861-01	1 in 1 CARTON	04/03/2026
1	NDC: 66738-861-21	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	04/03/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	manufacture(66738-861)