NDC 71644-001

Ava Isa Aurora Rose SPF 45

Zinc Oxide

Ava Isa Aurora Rose SPF 45 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Cyberderm Laboratories Inc.. The primary component is Zinc Oxide.

Product ID71644-001_626c47bc-bbc1-d84f-e053-2a91aa0af956
NDC71644-001
Product TypeHuman Otc Drug
Proprietary NameAva Isa Aurora Rose SPF 45
Generic NameZinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-03-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameCyberderm Laboratories Inc.
Substance NameZINC OXIDE
Active Ingredient Strength15 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71644-001-50

1 BOTTLE in 1 CARTON (71644-001-50) > 50 mL in 1 BOTTLE
Marketing Start Date2018-03-30
Marketing End Date2021-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71644-001-80 [71644000180]

Ava Isa Aurora Rose SPF 45 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-30

NDC 71644-001-50 [71644000150]

Ava Isa Aurora Rose SPF 45 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-30

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE15 g/100mL

OpenFDA Data

SPL SET ID:626c47bc-bbc0-d84f-e053-2a91aa0af956
Manufacturer
UNII

NDC Crossover Matching brand name "Ava Isa Aurora Rose SPF 45" or generic name "Zinc Oxide"

NDCBrand NameGeneric Name
71644-001Ava Isa Aurora Rose SPF 45Ava Isa Aurora Rose SPF 45
0316-2082Blue Lizard Active SPF 50zinc oxide
0316-2011Blue Lizard Baby SPF 50zinc oxide
0316-2012Blue Lizard Kids SPF 50zinc oxide
0316-2081Blue Lizard Kids SPF 50zinc oxide
0316-2013Blue Lizard Sensitive SPF 50zinc oxide
0316-2083Blue Lizard Sensitive SPF 50zinc oxide
0316-2080Blue Lizard Sport SPF 50zinc oxide
0132-0194BoudreauxsZinc Oxide
0132-0323BoudreauxsZinc Oxide
0132-0324BoudreauxsZinc Oxide
0132-0333BoudreauxsZinc Oxide
0132-0334BoudreauxsZinc Oxide
0132-0325Boudreauxs Rash Kicking KitZinc oxide
0201-4008CALENDULA DIAPER RASHZINC OXIDE
0164-2189CALENDULA DIAPER RASH CREAMZINC OXIDE
0299-4110Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50zinc oxide
0178-0330DR SMITHS DIAPERZinc Oxide
0178-0340Dr Smiths Diaper RashZinc Oxide
0178-0345Dr Smiths Diaper RashZinc Oxide
0178-0348Dr Smiths Diaper RashZinc Oxide
0178-0370Dr. Smiths Rash and SkinZinc Oxide
0363-0402Walgreen Maximum Strength Diaper RashZINC OXIDE
0363-0994Walgreens 50 Baby Mineral SunscreenZinc Oxide
0363-0988Walgreens SPF 50 Mineral SunscreenZINC OXIDE
0363-4008Walgreens SunscreenSPF 45 SPF 45ZINC OXIDE
0164-2207WHITE MALLOW DIAPER RASH CREAMZINC OXIDE
0168-0062ZINC OXIDEZINC OXIDE
0363-1020Zinc OxideZINC OXIDE
0363-1226Zinc oxideZinc oxide

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