Active Ingrdient
Octyl Methoxycinnamate - 9% (90 mg/ml)4-Methylbenzylidene Camphor - 1.3% (13 mg/ml)Zinc Oxide - 8% (80 mg/ml)
Outback 2-in-1
FDA Label NDC 43979-445
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elmore Oil Company Pty Ltd for the product Outback 2-in-1 (NDC 43979-445). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingrdient, purpose, indication and usage, dosage and administration, warnings, inactive ingredients, keep out of reach of children, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (Obc1)
Obc 2 Lab (Obc2)
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