Jurlique SPF40 High Protection Sunscreen

Manufacturer
Jurlique International | Cosmetic Laboratories of America
Effective date
2016-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:37

Label at a glance#

ProductJurlique SPF40 High Protection Sunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure9 sections

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includi...

Storage and handling

protect this product from excessive heat and direct sun Store below 30°C/86°F product may cause discolouration in contact with some fabric patch testing on skin recommended before use, discontinue use if signs of irritation occur you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone, 3.0%
Octinoxate, 7.5 %
Octocrylene, 2.75%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • help prevent sunburn

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • Store below 30°C/86°F
  • product may cause discolouration in contact with some fabric
  • patch testing on skin recommended before use, discontinue use if signs of irritation occur
  • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Phenoxyethyl Caprylate, Acrylates/Vinyl Neodecanoate Crosspolymer, Glycerin, Ethylhexyl Methoxycrylene, Diethylhexyl Syringylidenemalonate, Glyceryl Stearate, VP/Eicosene Copolymer, Cetearyl Alcohol, Myristyl Myristate, Sodium Stearoyl Glutamate, Plukenetia volubilis Seed Oil, Butyrospermum parkii (Shea) Butter, Palmaria palmata Extract, Ascophyllum nodosum Extract, Fucus vesiculosus Extract, Porphyra umbilicalis Extract, Corandrum sativum (Coriander) Extract, Chamomilla recutita (Matricaria) Flower Extract, Rosa gallica Flower Extract, Glycyrrhiza glabra (Licorice) Extract, Viola odorata Extract, Viola tricolor Extract, Sambucus nigra Flower Extract, Camellia sinensis Leaf Extract, Cucumis sativus (Cucumber) Fruit Extract, Tasmannia lanceolata Fruit Extract, Syzygium leuhmanii Extract, Kunzea pomifera Fruit Extract, Fragrance/Parfum1, Silica, Acrylates/Beheneth-25 methacrylate Copolymer, Xanthan Gum, Sodium Stearoyl Lactylate, Tocopherol, SD Alcohol 40-A (Alcohol Denat.), Sodium Phytate, Caprylic/Capric Triglyceride, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Sodium Dehydroacetate, Benzyl Alcohol, Sodium PCA, Sodium Hydroxide, Limonene1, Linalool1, Citronellol1, Geraniol1, Farnesol1, Citral1.

1 From Essential Oil

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jurlique

Sun Specialist
with Superberry Complex

SPF40
High Protection Cream
PA+++

Protective broad spectrum
sunscreen for face and body

100mL 3.3 fl. oz.

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68105-006-012020-01-31C16284748780-19d75b9d0-4cc3-f424-e053-dadaa90a57ceJurlique SPF40 High Protection Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68105-006-01Jurlique SPF40 High Protection Sunscreen100 mL in 1 TUBECREAM1001
68105-006-01Jurlique SPF40 High Protection Sunscreen1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68105-006JURLIQUE SPF40 HIGH PROTECTION SUNSCREEN (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [JURLIQUE INTERNATIONAL]1Legacy NDC, 2 package rows20160726_80683894-06ed-42f4-aa32-0fd4eb7e9166.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68105-00668105-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 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
d1410464-efb4-487f-a76a-a3c6abc956a180683894-06ed-42f4-aa32-0fd4eb7e91662016-07-25WarningsExact identifier
spl id: d1410464-efb4-487f-a76a-a3c6abc956a1
spl set id: 80683894-06ed-42f4-aa32-0fd4eb7e9166

Reported adverse events (FAERS/openFDA)#

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