Jurlique Purely Sun-Defying

Manufacturer
Jurlique International Pty. Ltd. | Cosmetic Laboratories of America
Effective date
2011-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:58

Label at a glance#

ProductJurlique Purely Sun-Defying Moisturizer with SPF 15 Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 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

Storage and handling

protect this product from excessive heat and direct sun 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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Zinc Oxide, 4.8%
Titanium Dioxide, 2.1%
bracket imagebracket imageSunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Simmondsia chinensis (Jojoba) Seed Oil, Glyceryl Stearate Citrate, Glycerin, Caprylic/Capric Triglyceride, Macadamia integrifolia Seed Oil, Mauritia flexuosa Fruit Oil, Sorbitan Palmitate, Glyceryl Isostearate, Porphyra umbilicalis Extract, Ectoin, Sambucus nigra (Black Elder) Flower Extract, Viola tricolor (Pansy) Extract, Viola odorata (Sweet Violet) Extract, Glycyrrhiza glabra (Licorice) Root Extract, Rosa gallica Flower Extract, Chamomilla recutita (Matricaria) Flower Extract, Althaea officinalis (Marshmallow) Root Extract, Polyhydroxystearic Acid, Lecithin, Sodium Lactate, Aluminum Hydroxide, Hydrated Silica, Alginic Acid, Beta-Glucan, Sodium Hyaluronate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Sodium Phytate, Bisabolol, SD Alcohol 40-A, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Totarol, Citrus medica limonum (Lemon) Peel Oil, Lavandula angustifolia (Lavender) Oil, Pelargonium graveolens Flower Oil, Fusanus spicatus Wood Oil, Citrus aurantium dulcis (Orange) Flower Oil, Anthemis nobilis Flower Extract, Pogostemon cablin Oil, Jasminum officinale (Jasmine) Flower Extract, Canarium luzonicum Gum Nonvolatiles.

PRINCIPAL DISPLAY PANEL - 40g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jurlique

Purely Sun-Defying

Moisturizer with
SPF 15 Sunscreen

A high performance
protective cream

e 40g Net wt. 1.4 oz.

Principal Display Panel - 40g Tube Carton
Principal Display Panel - 40g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68105-004-012019-10-29C16284748780-1960f7f55-d2e3-8e05-e053-dbdaa90a074aJurlique Purely Sun-Defying

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68105-004-01Jurlique Purely Sun-Defying Moisturizer with SPF 15 Sunscreen40 g in 1 TUBECREAM, AUGMENTED401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68105-004JURLIQUE PURELY SUN-DEFYING (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM, AUGMENTED [JURLIQUE INTERNATIONAL PTY. LTD.]1Legacy NDC, 1 package rows20111101_adefebbc-9a6c-41f6-92c9-48cb12800025.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALGINIC ACIDINACTIVE INGREDIENT8C3Z4148WZ1
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47H1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ1
CITRUS SINENSIS FLOWER OILINACTIVE INGREDIENTAJ56JP5TFP1
ECTOINEINACTIVE INGREDIENT7GXZ3858RY1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV1
ELEMIINACTIVE INGREDIENTC13XI009KO1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAO1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0651
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P91
JASMINUM OFFICINALE FLOWERINACTIVE INGREDIENT0Q8K8414321
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MACADAMIA OILINACTIVE INGREDIENT515610SU8C1
MAURITIA FLEXUOSA FRUIT OILINACTIVE INGREDIENT48H19MS04L1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
PATCHOULI OILINACTIVE INGREDIENTF3IN55X5PO1
PELARGONIUM GRAVEOLENS FLOWER OILINACTIVE INGREDIENT3K0J1S7QGC1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
ROSA GALLICA FLOWERINACTIVE INGREDIENTX8W61WUV701
SAMBUCUS NIGRA FLOWERINACTIVE INGREDIENT07V4DX094T1
SANTALUM SPICATUM OILINACTIVE INGREDIENTH9LVS6REV41
SIMMONDSIA CHINENSIS SEEDINACTIVE INGREDIENTD24K2Q1F6H1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT1
SORBITAN MONOPALMITATEINACTIVE INGREDIENT77K6Z421KU1
VIOLA ODORATAINACTIVE INGREDIENTAET12U8B741
VIOLA TRICOLORINACTIVE INGREDIENT9Q24RAI43V1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68105-00468105-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 229 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTINJECTION, SOLUTION / INFILTRATION0.17 %v/vExact identifier — unii candidate
7 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITAN MONOPALMITATESORBITAN MONOPALMITATE77K6Z421KULOTION / TOPICAL20 mgExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL ISOSTEARATEGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / VAGINAL135 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
ALGINIC ACIDALGINIC ACID8C3Z4148WZTABLET, FILM COATED / ORAL52.8 mgExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITAN MONOPALMITATESORBITAN MONOPALMITATE77K6Z421KULIQUID / TOPICAL2 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0TABLET / ORAL50 mgExact identifier — unii candidate
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL ISOSTEARATEGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / TOPICAL2 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
1027a948-e345-4f76-9c3c-91256e8d9d30adefebbc-9a6c-41f6-92c9-48cb128000252011-09-13WarningsExact identifier
spl id: 1027a948-e345-4f76-9c3c-91256e8d9d30
spl set id: adefebbc-9a6c-41f6-92c9-48cb12800025

Reported adverse events (FAERS/openFDA)#

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