Label: OUTBACK SERIES 2-IN-1 SUNSCREEN- octyl methoxycinnamate,avobenzone and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43979-446-01, 43979-446-03 - Packager: Elmore Oil Company Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 11, 2013
If you are a consumer or patient please visit this version.
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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 SERIES 2-IN-1 SUNSCREEN
octyl methoxycinnamate,avobenzone and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43979-446 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 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) CITRONELLA OIL (UNII: QYO8Q067D0) TEA TREE OIL (UNII: VIF565UC2G) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43979-446-01 3 mL in 1 POUCH 2 NDC:43979-446-03 75 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2013 Labeler - Elmore Oil Company Pty Ltd (755881968) Establishment Name Address ID/FEI Business Operations Elmore Oil Company Pty Ltd 755881968 manufacture(43979-446) , pack(43979-446) , label(43979-446)