OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN- octinoxate,4-methylbenzylidene camphor and zinc cream 
Elmore Oil Company Pty Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingrdient

Octyl Methoxycinnamate - 9% (90 mg/ml)
4-Methylbenzylidene Camphor - 1.3%  (13 mg/ml)
Zinc Oxide - 8% (80 mg/ml)

Purpose

Sunscreen and Insect Repellent.

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

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

Keep Out of Reach of Children

Product Label


obc 1 lab

obc 2 lab




OUTBACK 2-IN-1  INSECT REPELLENT AND PROTECTIVE SUNSCREEN
octinoxate,4-methylbenzylidene camphor and zinc cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43979-445
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE90 mg  in 1 mL
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE13 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
TEA TREE OIL (UNII: VIF565UC2G)  
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA (vanila) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43979-445-013 mL in 1 POUCH
2NDC:43979-445-0350 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2012
Labeler - Elmore Oil Company Pty Ltd (755881968)
Establishment
NameAddressID/FEIBusiness Operations
Elmore Oil Company Pty Ltd755881968manufacture, pack, label

Revised: 6/2012
Document Id: 3b04cd1f-ed03-47df-9315-1a085ec373c1
Set id: ea926d9b-7bb5-4480-98b8-d80e4b3f1a67
Version: 1
Effective Time: 20120611
 
Elmore Oil Company Pty Ltd