Jack Black

spiced citrus

Approved

Approval ID

3e0f655e-6100-f1dd-e063-6394a90af7b7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 5, 2025

Manufacturers

FDA

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

NDC Product Code66738-171

Application NumberM020

Product Classification

Marketing Category

C200263

Generic Name

Avobenzone/Homosalate/Octisalate/Petrolatum

Product Specifications

Route of AdministrationTOPICAL

Effective DateSeptember 5, 2025

FDA Product Classification

INGREDIENTS (34)

OCTISALATEActive

Quantity: 5 g in 100 mL

Code: 4X49Y0596W

Classification: ACTIB

CITRALInactive

Code: T7EU0O9VPP

Classification: IACT

PINENEInactive

Code: 996299PUKB

Classification: IACT

ETHYLHEXYL METHOXYCRYLENEInactive

Code: S3KFG6Q5X8

Classification: IACT

AVOBENZONEActive

Quantity: 3 g in 100 mL

Code: G63QQF2NOX

Classification: ACTIB

HOMOSALATEActive

Quantity: 10 g in 100 mL

Code: V06SV4M95S

Classification: ACTIB

EUPHORBIA CERIFERA (CANDELILLA) WAXInactive

Code: WL0328HX19

Classification: IACT

CITRONELLOLInactive

Code: P01OUT964K

Classification: IACT

TERPINEOLInactive

Code: R53Q4ZWC99

Classification: IACT

METHYL SALICYLATEInactive

Code: LAV5U5022Y

Classification: IACT

POLYGLYCERYL-3 BEESWAXInactive

Code: Z98M8HW9A6

Classification: IACT

LINALOOLInactive

Code: D81QY6I88E

Classification: IACT

BETA-CARYOPHYLLENEInactive

Code: BHW853AU9H

Classification: IACT

HYDROGENATED SOYBEAN OILInactive

Code: A2M91M918C

Classification: IACT

EUGENOLInactive

Code: 3T8H1794QW

Classification: IACT

HELIANTHUS ANNUUS (SUNFLOWER) SEED OILInactive

Code: 3W1JG795YI

Classification: IACT

THEOBROMA CACAO (COCOA) SEED BUTTERInactive

Code: 512OYT1CRR

Classification: IACT

PETROLATUMActive

Quantity: 40.2 g in 100 mL

Code: 4T6H12BN9U

Classification: ACTIB

BEESWAXInactive

Code: 2ZA36H0S2V

Classification: IACT

CAMELLIA SINENSIS LEAFInactive

Code: W2ZU1RY8B0

Classification: IACT

SYNTHETIC BEESWAXInactive

Code: 08MNR5YE2R

Classification: IACT

CETYL ALCOHOLInactive

Code: 936JST6JCN

Classification: IACT

BUTYROSPERMUM PARKII (SHEA) BUTTERInactive

Code: K49155WL9Y

Classification: IACT

VANILLINInactive

Code: CHI530446X

Classification: IACT

CITRUS AURANTIUM PEEL OILInactive

Code: 9TLV70SV6I

Classification: IACT

LIMONENE, (+)-Inactive

Code: GFD7C86Q1W

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

CERESINInactive

Code: Q1LS2UJO3A

Classification: IACT

PERSEA GRATISSIMA (AVOCADO) OILInactive

Code: 6VNO72PFC1

Classification: IACT

HYDROGENATED COCONUT OILInactive

Code: JY81OXM1OM

Classification: IACT

BUTYLOCTYL SALICYLATEInactive

Code: 2EH13UN8D3

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

POGOSTEMON CABLIN OILInactive

Code: F3IN55X5PO

Classification: IACT

CARVONEInactive

Code: 75GK9XIA8I

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/1/2025

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2025

Use

• Helps protect against sunburn and chapped lips.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2025

Active ingredients

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2025

Purposes

Sunscreen

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2025

Warning

Stop use if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/1/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2025

Directions

• Apply liberally before sun exposure and reapply every 2 hours.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2025

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, Tocopheryl Acetate, Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Eugenol, Lecithin, Citrus Aurantium Peel Oil, Limonene, Helianthus Annuus (Sunflower) Seed Oil, Linalool, Microcrystalline Wax, Methyl Salicylate, Pogostemon Cablin Oil, Vanillin, beta-Caryophyllene, Citronellol, Rose Ketones, Citral, Camellia Sinensis Leaf Extract, Terpineol, Pinene, Carvone

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2025

Questions?

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

AI-Powered Research

Premium Access

Jack Black

Products 1

Avobenzone/Homosalate/Octisalate/Petrolatum

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (34)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INDICATIONS & USAGE SECTION

Use

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

OTC - PURPOSE SECTION

Purposes

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

Directions

INACTIVE INGREDIENT SECTION

Inactive ingredients

OTC - QUESTIONS SECTION

Questions?

MedPath

Product

Company

Legal