FDA.reportPublic FDA data

Jurlique Sun Lotion Sunscreen SPF 30

Manufacturer
Jurlique International Pty. Ltd.
Effective date
2012-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:08

Label at a glance#

ProductJurlique Sun Sunscreen SPF 30
Active ingredientOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
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

Storage and handling

protect this product from excessive heat and direct sunlight store below 25°C/77°F you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 2.0%
Oxybenzone 5.0%
Titanium dioxide 2.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 help prevent sunburn, not skin cancer or early skin aging.

OTC - DO NOT USE SECTION

For external use only

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 sunlight
  • store below 25°C/77°F
  • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Ethylhexyl Stearate, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Glyceryl Stearate, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexyl Palmitate, Dimethicone, Trimethylsiloxysilicate, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Sodium Hydroxymethylglycinate, Lactic Acid, Alumina, Stearic Acid, Xanthan Gum, Cetyl Alcohol, Lavandula Angustifolia (Lavender) Oil, Pinus Sylvestris (Pine) Leaf Oil, Cupressus Sempervirens (Cypress) Oil, Citrus Aurantium Amara (Bitter Orange) Oil, Linalool, Limonene.

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jurlique

Sun Lotion

SPF 30

A protective sunscreen lotion

100mL 3.3 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68105-005-032019-11-27C16284748780-19855d018-e6f9-cd31-e053-dbdaa90ab51aJurlique Sun Lotion Sunscreen SPF 30
68105-005-042019-11-27C16284748780-19855d018-e6f9-cd31-e053-dbdaa90ab51aJurlique Sun Lotion Sunscreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68105-005-01Jurlique Sun Sunscreen SPF 30100 mL in 1 BOTTLE, PUMPCREAM, AUGMENTED1001
68105-005-02Jurlique Sun Sunscreen SPF 3030 mL in 1 BOTTLE, PUMPCREAM, AUGMENTED301
68105-005-03Jurlique Sun Sunscreen SPF 301 in 1 CARTONCREAM, AUGMENTED11
68105-005-04Jurlique Sun Sunscreen SPF 301 in 1 CARTONCREAM, AUGMENTED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68105-005JURLIQUE SUN SUNSCREEN SPF 30 (OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM, AUGMENTED [JURLIQUE INTERNATIONAL PTY. LTD.]1Legacy NDC, 4 package rows20130101_9eb16d04-460f-49c3-a88b-f95eaee21feb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
Aluminum OxideINACTIVE INGREDIENTLMI26O69331
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
BITTER ORANGE OILINACTIVE INGREDIENT9TLV70SV6I1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Ethylhexyl PalmitateINACTIVE INGREDIENT28659933091
Ethylhexyl StearateINACTIVE INGREDIENTEG3PA2K3K51
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YL1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
LIMONENE, (+/-)-INACTIVE INGREDIENT9MC3I344471
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y1
Potassium Cetyl PhosphateINACTIVE INGREDIENT03KCY6P7UT1
Sodium HydroxymethylglycinateINACTIVE INGREDIENTDIG6BWZ9XT1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68105-00568105-005-01, 68105-005-03, 68105-005-02, 68105-005-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
Oxybenzone95OOS7VE0YACTIB
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Ethylhexyl StearateEG3PA2K3K5IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
Ethylhexyl Palmitate2865993309IACT
Dimethicone92RU3N3Y1OIACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Sodium HydroxymethylglycinateDIG6BWZ9XTIACT
Lactic Acid33X04XA5ATIACT
Aluminum OxideLMI26O6933IACT
Stearic Acid4ELV7Z65APIACT
Xanthan GumTTV12P4NEEIACT
Cetyl Alcohol936JST6JCNIACT
LAVENDER OILZBP1YXW0H8IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
BITTER ORANGE OIL9TLV70SV6IIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LIMONENE, (+/-)-9MC3I34447IACT

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 · 215 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii candidate
18 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATSOLUTION / ORAL192 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / VAGINAL140 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL201 mgExact identifier — unii candidate
20 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEAEROSOL, FOAM / TOPICAL0.27 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATCREAM / TOPICAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATTABLET / ORALADJ PHExact identifier — unii candidate
18 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS336 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 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
4b7fb903-ee50-4b07-81c6-e0023b6529419eb16d04-460f-49c3-a88b-f95eaee21feb2012-11-21WarningsExact identifier
spl id: 4b7fb903-ee50-4b07-81c6-e0023b652941
spl set id: 9eb16d04-460f-49c3-a88b-f95eaee21feb

Reported adverse events (FAERS/openFDA)#

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