OUTBACK SERIES 2-IN-1 SUNSCREEN- octyl methoxycinnamate,avobenzone and zinc oxide cream

Outback Series 2-in-1 Sunscreen by

Drug Labeling and Warnings

Outback Series 2-in-1 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Elmore Oil Company Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingrdient

Octyl Methoxycinnamate - 7.5%

 Avobenzone - 1.3%

 Zinc Oxide - 9.5%

Purpose

Sunscreen 30+

Indication and Usage

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

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

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

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

Keep out of Reach of Children

Keep Out of Reach of Children

Product Label

INGREDIENTS AND APPEARANCE

OUTBACK SERIES 2-IN-1 SUNSCREEN 
octyl methoxycinnamate,avobenzone and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43979-446
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	13 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)
CITRONELLA OIL (UNII: QYO8Q067D0)
TEA TREE OIL (UNII: VIF565UC2G)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43979-446-01	3 mL in 1 POUCH
2	NDC: 43979-446-03	75 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2013

Labeler - Elmore Oil Company Pty Ltd (755881968)

Establishment
Name	Address	ID/FEI	Business Operations
Elmore Oil Company Pty Ltd		755881968	manufacture(43979-446) , pack(43979-446) , label(43979-446)