NDC 69594-005

Outback 2 in 1 Protection

Octinoxate,avobenzone And Zinc Oxide

Outback 2 in 1 Protection is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Ultra Mix (aust) Pty Ltd. The primary component is Octinoxate; Avobenzone; Zinc Oxide.

Product ID69594-005_f7473b9a-663a-4b24-b603-69f765faa818
NDC69594-005
Product TypeHuman Otc Drug
Proprietary NameOutback 2 in 1 Protection
Generic NameOctinoxate,avobenzone And Zinc Oxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2015-02-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameUltra Mix (Aust) Pty Ltd
Substance NameOCTINOXATE; AVOBENZONE; ZINC OXIDE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69594-005-01

75 mL in 1 TUBE (69594-005-01)
Marketing Start Date2015-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69594-005-01 [69594000501]

Outback 2 in 1 Protection CREAM
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-02-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:95adf725-b16a-4617-bbe3-105b82de3961
Manufacturer
UNII

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