NDC 43979-446

Outback Series 2-in-1 Sunscreen

Octyl Methoxycinnamate,avobenzone And Zinc Oxide

Outback Series 2-in-1 Sunscreen is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Elmore Oil Company Pty Ltd. The primary component is Octinoxate; Avobenzone; Zinc Oxide.

Product ID43979-446_28745142-046e-4552-bd9b-1653fbb1a647
NDC43979-446
Product TypeHuman Otc Drug
Proprietary NameOutback Series 2-in-1 Sunscreen
Generic NameOctyl Methoxycinnamate,avobenzone And Zinc Oxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameElmore Oil Company Pty Ltd
Substance NameOCTINOXATE; AVOBENZONE; ZINC OXIDE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43979-446-01

3 mL in 1 POUCH (43979-446-01)
Marketing Start Date2013-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43979-446-03 [43979044603]

Outback Series 2-in-1 Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Inactivation Date2019-11-27

NDC 43979-446-01 [43979044601]

Outback Series 2-in-1 Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:b7453351-ac07-443a-bea9-e1cd8dc2ca9b
Manufacturer
UNII

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