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Outback 2-in-1 Insect Repellent and Protective Sunscreen

Dosage form: cream
Ingredients: OCTINOXATE 90mg in 1mL, ENZACAMENE 13mg in 1mL, Zinc Oxide 80mg in 1mL
Labeler: Elmore Oil Company Pty Ltd
NDC Code: 43979-445

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.

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

Keep out of Reach of ChildrenKeep Out of Reach of Children

Product Label




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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE90 mg  in 1 mL
ENZACAMENE (ENZACAMENE) ENZACAMENE13 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EUCALYPTUS POLYBRACTEA LEAF OIL 
LEPTOSPERMUM PETERSONII LEAF OIL 
TEA TREE OIL 
Product Characteristics
Color    Score    
ShapeSize
FlavorVANILLA (vanila) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Elmore Oil Company Pty Ltd755881968manufacture, pack, label

Revised: 06/2012
 
Elmore Oil Company Pty Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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