Outback 2-in-1

Manufacturer: Elmore Oil Company Pty Ltd
Effective date: 2012-06-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:28

Label at a glance#

ProductOutback 2-in-1 Insect Repellent and Protective Sunscreen

Active ingredientOCTINOXATE, ENZACAMENE, 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 - 9% (90 mg/ml)
4-Methylbenzylidene Camphor - 1.3% (13 mg/ml)
Zinc Oxide - 8% (80 mg/ml)

Purpose

OTC - PURPOSE SECTION

Sunscreen and Insect Repellent.

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

Eucalyptus Leaf Oil (Eucalyptus Polybractea), Leptospermum Petersonii Leaf Oil (Leptospermum Petersonii), Tea Tree Oil ( Melaleuca Alternifolia) Vanilla,Actilastin 1000,

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 lab

obc 2 lab

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43979-445-01	2019-11-13	C162847	48780-1	97449f38-c0da-f6ea-e053-dbdaa90aa703	ea926d9b-7bb5-4480-98b8-d80e4b3f1a67
43979-445-03	2019-11-13	C162847	48780-1	97449f38-c0da-f6ea-e053-dbdaa90aa703	ea926d9b-7bb5-4480-98b8-d80e4b3f1a67

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43979-445-01	Outback 2-in-1Insect Repellent and Protective Sunscreen	3 mL in 1 POUCH	CREAM	3		1
43979-445-03	Outback 2-in-1Insect Repellent and Protective Sunscreen	50 mL in 1 BOTTLE	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43979-445	OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN (OCTINOXATE,4-METHYLBENZYLIDENE CAMPHOR AND ZINC) CREAM [ELMORE OIL COMPANY PTY LTD]	1	Legacy NDC, 2 package rows	20120701_ea926d9b-7bb5-4480-98b8-d80e4b3f1a67.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ENZACAMENE	ACTIVE INGREDIENT	8I3XWY40L9	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
ENZACAMENE	ACTIVE MOIETY	8I3XWY40L9	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
EUCALYPTUS POLYBRACTEA LEAF OIL	INACTIVE INGREDIENT	J1XGA6WROO	1
LEPTOSPERMUM PETERSONII LEAF OIL	INACTIVE INGREDIENT	N37UWG52T3	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Outback 2-in-1 Insect Repellent and Protective Sunscreen
Octinoxate,4-Methylbenzylidene Camphor and Zinc
OCTINOXATE
ENZACAMENE
Zinc Oxide
EUCALYPTUS POLYBRACTEA LEAF OIL
LEPTOSPERMUM PETERSONII LEAF OIL
TEA TREE OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43979-445	43979-445-01, 43979-445-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
ENZACAMENE	8I3XWY40L9	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
EUCALYPTUS POLYBRACTEA LEAF OIL	J1XGA6WROO	IACT
LEPTOSPERMUM PETERSONII LEAF OIL	N37UWG52T3	IACT
TEA TREE OIL	VIF565UC2G	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3b04cd1f-ed03-47df-9315-1a085ec373c1			ea926d9b-7bb5-4480-98b8-d80e4b3f1a67	2012-06-11	Warnings	Exact identifier spl id: 3b04cd1f-ed03-47df-9315-1a085ec373c1 spl set id: ea926d9b-7bb5-4480-98b8-d80e4b3f1a67

Reported adverse events (FAERS/openFDA)#

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