FDA.reportPublic FDA data

JACKET SPF-50 Broad Spectrum Sunscreen

Manufacturer
BALSHI MD DERMACEUTICALS
Effective date
2024-08-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:18:13

Label at a glance#

ProductJACKET SPF-50 Broad Spectrum Sunscreen
Active ingredientZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: *Limit time in the sun, especial...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 6.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only.

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

OTC - STOP USE SECTION

if irritation or rash develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: *Limit time in the sun, especially between 10am -2pm *Wear long sleeve shirts, pants, hats and sunglasses *For children under 6 months, consult a physician.

Sun Protection Measures:

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71070-868-04JACKET SPF-50 Broad Spectrum Sunscreen120 mL in 1 TUBELOTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71070-868JACKET SPF-50 BROAD SPECTRUM SUNSCREEN (ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [BALSHI MD DERMACEUTICALS]3Current NDC, Legacy NDC, 1 package rows20240830_fcc45edd-098c-4f27-9712-0db36cfa0fdc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71070-86871070-868-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
CYMBOPOGON CITRATUS LEAF06JMS448M5IACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LICORICE61ZBX54883IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POMEGRANATE56687D1Z4DIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
ZINC OXIDESOI2LOH54ZACTIM
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JACKET SPF-50 Broad Spectrum SunscreenZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSfcc45edd-098c-4f27-9712-0db36cfa0fdc2024-08-29WarningsExact identifier
ndc (package): 71070-868-04
ndc (product): 71070-868
ndc11 (package): 71070086804
spl id: 20ce424e-ca59-9b97-e063-6394a90abfba
spl set id: fcc45edd-098c-4f27-9712-0db36cfa0fdc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.