Outback Series 2-in-1 Sunscreen description, usages, side effects, indications, overdosage, supplying and lots more!

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Outback Series 2-in-1 Sunscreen

Elmore Oil Company Pty Ltd


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingrdient

Octyl Methoxycinnamate - 7.5%

 Avobenzone - 1.3%

 Zinc Oxide - 9.5%

Purpose

Sunscreen 30+

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

Actilastin 1000, Melaleuca Alternifolia, Eucalyptus Polybractea, Citronella, Leptospermum Petersonii, Vanilla

Keep out of Reach of Children

Keep Out of Reach of Children

Product Label


Outback Series 2-in-1 Sunscreen

Outback Series 2-in-1 Sunscreen




Outback Series 2-in-1 Sunscreen

Octyl Methoxycinnamate,Avobenzone and Zinc Oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43979-446
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
AVOBENZONE AVOBENZONE 13 mg
Zinc Oxide Zinc oxide 80 mg

Inactive Ingredients

Ingredient Name Strength
EUCALYPTUS POLYBRACTEA LEAF OIL
LEPTOSPERMUM PETERSONII LEAF OIL
CITRONELLA OIL
TEA TREE OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43979-446-01 3 in 1 POUCH
2 NDC:43979-446-03 75 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-07-01


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