Jack Black
3d5fafb9-62c9-ec69-e063-6394a90af8b9
HUMAN OTC DRUG LABEL
Sep 5, 2025
Jack Black L.L.C.
DUNS: 847024036
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Avobenzone/Homosalate/Octisalate/Petrolatum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (23)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
• Helps protect against sunburn and chapped lips.
OTC - ACTIVE INGREDIENT SECTION
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Petrolatum 40.2%
OTC - PURPOSE SECTION
Purposes
Sunscreen
Sunscreen
Sunscreen
Skin protectant
WARNINGS SECTION
Warning
Stop use if skin rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
• Apply liberally before sun exposure and reapply every 2 hours.
INACTIVE INGREDIENT SECTION
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.
OTC - QUESTIONS SECTION
Questions?
1-469-341-2700; 1-877-766-3388 www.getJackBlack.com