FDA.reportPublic FDA data

Jacket Ultimate Performance Sunscreen SPF 30

Manufacturer
BALSHI MD DERMACEUTICALS | Pure Source, LLC
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:29

Label at a glance#

ProductJacket Ultimate Performance Sunscreen SPF 30
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin agingcaused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours do not spray directly on face. Spray into hands and apply to face. Use in well-ventilated areas. Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.00%)
Octisalate (5.00%)
Octocrylene (5.00%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agingcaused 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.

  • Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • do not spray directly on face. Spray into hands and apply to face.
  • Use in well-ventilated areas.
  • Sun Protection Measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.-2p.m.
  • Wear long-sleeved shirts, pants,hats,and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Leaf Extract, Alpha-Arbutin, Ascorbyl Palmitate, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus Oil, Helianthus Annuus (Sunflower) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Methyl Dihydroabietate, Nelumbo Nucifera Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Tocopheryl Acetate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CanCan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71070-599-00Jacket Ultimate Performance Sunscreen SPF 30177 mL in 1 CANLIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71070-599JACKET ULTIMATE PERFORMANCE SUNSCREEN SPF 30 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LIQUID [BALSHI MD DERMACEUTICALS]1Current NDC, 1 package rows20250507_d4d82c41-01da-40af-a22c-d4d57af7a2f2.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71070-59971070-599-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALPHA-ARBUTIN72VUP07IT5IACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCONUT OILQ9L0O73W7LIACT
CUCUMBERYY7C30VXJTIACT
CYMBOPOGON SCHOENANTHUS OILXE7K568ILOIACT
SUNFLOWER OIL3W1JG795YIIACT
LINSEED OIL84XB4DV00WIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
NELUMBO NUCIFERA FLOWER61W322NLDVIACT
SAGE065C5D077JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
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 Ultimate Performance Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSd4d82c41-01da-40af-a22c-d4d57af7a2f22025-05-05WarningsExact identifier
ndc (package): 71070-599-00
ndc (product): 71070-599
ndc11 (package): 71070059900
spl id: 3462c3ff-351f-de3c-e063-6394a90a947c
spl set id: d4d82c41-01da-40af-a22c-d4d57af7a2f2

Reported adverse events (FAERS/openFDA)#

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