Intensive Age Defying Hydrating Complex SPF 25

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 00:13:01

Label at a glance#

ProductIntensive Age Defying Hydrating Complex SPF 25
Active ingredientOCTINOXATE, AVOBENZONE, HOMOSALATE, OXYBENZONE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Homosalate 10.0%

Octinoxate 7.5%

Oxybenzone 5.0%

Avobenzone 3.0%

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

Directions ■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 swimming or sweating ■ Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water/Aqua/Eau, Water/ Aqua, Rosa Damascena Extract, Ceteareth-20, Cyclopentasiloxane, Glycerin, Cetearyl Alcohol, Caprylyl Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Punica Granatum Seed Oil, Sodium Lactate, Phoenix Dactylifera (Date) Fruit Extract, Caramel, Caprylhydroxamic Acid, Allantoin, Sodium Hydroxide, Panthenol, Sodium Phytate, Chlorella Vulgaris Extract, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Phenoxyethano, Arnica Montana Flower Extract, Oryza Sativa (Rice) Bran Extract, Glycine Soja (Soybean) Germ Extract, Silica, Leuconostoc/Radish Root Ferment Filtrate, Rosa Damascena Flower Oil, Hydrolyzed Elastin, Soluble Collagen, Alcohol, Camellia Sinensis Leaf Extract, Sodium Benzoate, Tetrasodium EDTA, Benzyl Benzoate, Citronellol, Geraniol.

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 ■ www.JUNEJACOBS.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IAD CARTONIAD CARTONIAD TUBEIAD TUBE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-103-01Intensive Age Defying Hydrating Complex SPF 2547.32 g in 1 TUBECREAM47.321
65278-103-02Intensive Age Defying Hydrating Complex SPF 2547.32 g in 1 CARTONCREAM47.321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-103INTENSIVE AGE DEFYING HYDRATING COMPLEX SPF 25 (HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC]1Current NDC, 2 package rows20240530_18f59d9d-1328-d815-e063-6294a90a3801.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65278-10365278-103-01, 65278-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 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
Intensive Age Defying Hydrating Complex SPF 25HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONEJune Jacobs Labs, LLC18f59d9d-1328-d815-e063-6294a90a38012024-05-21WarningsExact identifier
ndc (package): 65278-103-01
ndc (package): 65278-103-02
ndc (product): 65278-103
ndc11 (package): 65278010301
ndc11 (package): 65278010302
spl id: 18f59d9d-1329-d815-e063-6294a90a3801
spl set id: 18f59d9d-1328-d815-e063-6294a90a3801

Reported adverse events (FAERS/openFDA)#

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