Advanced Sun Resistance SPF 30

Manufacturer
June Jacobs Labs, LLC
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:00

Label at a glance#

ProductAdvanced Sun Resistance SPF 30
Active ingredientAVOBENZONE, OXYBENZONE, OCTINOXATE, HOMOSALATE, OCTISALATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Homosalate 10.00%

Octinoxate 7.50%

Oxybenzone 6.00%

Octisalate 5.00%

Avobenzone 3.00%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. – 2 p.m.

• wear long sleeve shirts, pants, hats, and sunglasses

■ Reapply at least every 2 hours

■ Use a water resistant sunscreen if swim ming or sweating

■ Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral

OTHER SAFETY INFORMATION

Other information

■ Protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-866-JUNEJACOBS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADVSunSPF30 CartonADVSunSPF30 CartonADVSunSPF30 TubeADVSunSPF30 Tube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-319-01Advanced Sun Resistance SPF 30112.38 g in 1 TUBECREAM112.381
65278-319-02Advanced Sun Resistance SPF 30112.38 g in 1 CARTONCREAM112.381

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-319ADVANCED SUN RESISTANCE SPF 30 (HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC]1Current NDC, 2 package rows20240529_18f879f0-3d5b-0067-e063-6394a90a9db3.zip

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65278-31965278-319-01, 65278-319-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

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
Advanced Sun Resistance SPF 30HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONEJune Jacobs Labs, LLC18f879f0-3d5b-0067-e063-6394a90a9db32024-05-21WarningsExact identifier
ndc (package): 65278-319-02
ndc (package): 65278-319-01
ndc (product): 65278-319
ndc11 (package): 65278031901
ndc11 (package): 65278031902
spl id: 18f879f0-3d5c-0067-e063-6394a90a9db3
spl set id: 18f879f0-3d5b-0067-e063-6394a90a9db3

Reported adverse events (FAERS/openFDA)#

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