FDA.reportPublic FDA data

Outback 2 in 1 Protection

Manufacturer
Ultra Mix (Aust) Pty Ltd
Effective date
2015-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:43

Label at a glance#

ProductOutback 2 in 1 Protection
Active ingredientOCTINOXATE, AVOBENZONE, ZINC OXIDE
Label structure6 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE : 7.5 % AVOBENZONE : 1.3% ZINC OXIDE :9.5%

Inactives

INACTIVE INGREDIENT SECTION

TEA TREE OIL

EUCALYPTUS POLYBRACTEA LEAF OIL

CITRONELLA OIL

LEPTOSPERMUM PETERSONII LEAF OIL

VANILLA

ACTILASTIN 1000

Purpose

OTC - PURPOSE SECTION

Sunscreen, helps prevent sunburn.

Directions of Usage

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  immediately.

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 of  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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunscreensunscreen

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69594-005-012020-01-31C16284748780-19d75b9d0-866e-f424-e053-dadaa90a57ceOutback 2 in 1 Protection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69594-005-01Outback 2 in 1 Protection75 mL in 1 TUBECREAM751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69594-005OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ]1Legacy NDC, 1 package rows20150217_95adf725-b16a-4617-bbe3-105b82de3961.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC CATIONACTIVE MOIETY13S1S8SF371
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 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69594-00569594-005-01

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 OXIDESOI2LOH54ZACTIM
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS POLYBRACTEA LEAF OILJ1XGA6WROOIACT
CITRONELLA OILQYO8Q067D0IACT
LEPTOSPERMUM PETERSONII LEAF OILN37UWG52T3IACT

Source Document#

Source XML · Source PDF

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
f7473b9a-663a-4b24-b603-69f765faa81895adf725-b16a-4617-bbe3-105b82de39612015-02-16WarningsExact identifier
spl id: f7473b9a-663a-4b24-b603-69f765faa818
spl set id: 95adf725-b16a-4617-bbe3-105b82de3961

Reported adverse events (FAERS/openFDA)#

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