FDA Label for Outback 2-in-1 Insect Repellent And Protective Sunscreen

View Indications, Usage & Precautions

Outback 2-in-1 Insect Repellent And Protective Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Elmore Oil Company Pty Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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








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