OUTBACK 2 IN 1 PROTECTION- octinoxate,avobenzone and zinc oxide cream

Outback 2 in 1 Protection by

Drug Labeling and Warnings

Outback 2 in 1 Protection by is a Otc medication manufactured, distributed, or labeled by Ultra Mix (Aust) Pty Ltd , Ultra Mix (Aust) Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Inactives

TEA TREE OIL

EUCALYPTUS POLYBRACTEA LEAF OIL

CITRONELLA OIL

LEPTOSPERMUM PETERSONII LEAF OIL

VANILLA

ACTILASTIN 1000

Purpose

Sunscreen, helps prevent sunburn.

Directions of Usage

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  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

INGREDIENTS AND APPEARANCE

OUTBACK 2 IN 1 PROTECTION 
octinoxate,avobenzone and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69594-005
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 CATION - UNII:13S1S8SF37)	ZINC CATION	95 mg  in 1 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69594-005-01	75 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/16/2015

Labeler - Ultra Mix (Aust) Pty Ltd (752254649)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Mix (Aust) Pty Ltd		752254649	manufacture(69594-005) , label(69594-005)