FDA.reportPublic FDA data

Outback Series 2-in-1 Sunscreen

Manufacturer
Elmore Oil Company Pty Ltd
Effective date
2013-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:50

Label at a glance#

ProductOutback Series 2-in-1 Sunscreen
Active ingredientOCTINOXATE, AVOBENZONE, Zinc Oxide
Label structure8 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

Label contents#

Full prescribing information#

Active ingrdient

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxycinnamate - 7.5%

 Avobenzone - 1.3%

 Zinc Oxide - 9.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen 30+

Indication and Usage

INDICATIONS & USAGE SECTION

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.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

Warnings

WARNINGS SECTION

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center right away.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF or 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


obc 1 labobc 1 lab

obc 2 labobc 2 lab


FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43979-446-012019-11-27C16284748780-19855d018-ea65-cd31-e053-dbdaa90ab51ab7453351-ac07-443a-bea9-e1cd8dc2ca9b
43979-446-032019-11-27C16284748780-19855d018-ea65-cd31-e053-dbdaa90ab51ab7453351-ac07-443a-bea9-e1cd8dc2ca9b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43979-446-01Outback Series 2-in-1 Sunscreen3 mL in 1 POUCHCREAM31
43979-446-03Outback Series 2-in-1 Sunscreen75 mL in 1 BOTTLECREAM751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43979-446OUTBACK SERIES 2-IN-1 SUNSCREEN (OCTYL METHOXYCINNAMATE,AVOBENZONE AND ZINC OXIDE) CREAM [ELMORE OIL COMPANY PTY LTD]1Legacy NDC, 2 package rows20130701_b7453351-ac07-443a-bea9-e1cd8dc2ca9b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D01
EUCALYPTUS POLYBRACTEA LEAF OILINACTIVE INGREDIENTJ1XGA6WROO1
LEPTOSPERMUM PETERSONII LEAF OILINACTIVE INGREDIENTN37UWG52T31
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43979-44643979-446-01, 43979-446-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
Zinc OxideSOI2LOH54ZACTIB
EUCALYPTUS POLYBRACTEA LEAF OILJ1XGA6WROOIACT
LEPTOSPERMUM PETERSONII LEAF OILN37UWG52T3IACT
CITRONELLA OILQYO8Q067D0IACT
TEA TREE OILVIF565UC2GIACT

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
28745142-046e-4552-bd9b-1653fbb1a647b7453351-ac07-443a-bea9-e1cd8dc2ca9b2013-06-11WarningsExact identifier
spl id: 28745142-046e-4552-bd9b-1653fbb1a647
spl set id: b7453351-ac07-443a-bea9-e1cd8dc2ca9b

Reported adverse events (FAERS/openFDA)#

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