Active Ingredients
OCTINOXATE : 7.5 % AVOBENZONE : 1.3% ZINC OXIDE :9.5%
Outback 2 In 1 Protection
FDA Label NDC 69594-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultra Mix (aust) Pty Ltd for the product Outback 2 In 1 Protection (NDC 69594-005). 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 ingredients, inactives, purpose, directions of usage, warnings, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Sunscreen (Sunscreen)
* Please review the disclaimer below.
