Label: OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN- octinoxate,4-methylbenzylidene camphor and zinc cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43979-445-01, 43979-445-03 - Packager: Elmore Oil Company Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 11, 2012
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- Active ingrdient
- Purpose
- Indication and Usage
- Dosage and Administration
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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
- Keep out of Reach of Children
- Product Label
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INGREDIENTS AND APPEARANCE
OUTBACK 2-IN-1 INSECT REPELLENT AND PROTECTIVE SUNSCREEN
octinoxate,4-methylbenzylidene camphor and zinc creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43979-445 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 90 mg in 1 mL ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE 13 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO) LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3) TEA TREE OIL (UNII: VIF565UC2G) Product Characteristics Color Score Shape Size Flavor VANILLA (vanila) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43979-445-01 3 mL in 1 POUCH 2 NDC:43979-445-03 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/01/2012 Labeler - Elmore Oil Company Pty Ltd (755881968) Establishment Name Address ID/FEI Business Operations Elmore Oil Company Pty Ltd 755881968 manufacture, pack, label