NDC 11045-0303

Soleo Organics Sunscreen

Zinc Oxide

Soleo Organics Sunscreen is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Se Operations Pty Ltd. The primary component is Zinc Oxide.

Product ID11045-0303_b389b6e6-9f4b-467d-9965-36736de8b533
NDC11045-0303
Product TypeHuman Otc Drug
Proprietary NameSoleo Organics Sunscreen
Generic NameZinc Oxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2007-01-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSE Operations Pty Ltd
Substance NameZINC OXIDE
Active Ingredient Strength223 mg/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 11045-0303-1

40 g in 1 TUBE (11045-0303-1)
Marketing Start Date2007-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11045-0303-2 [11045030302]

Soleo Organics Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-01-20

NDC 11045-0303-1 [11045030301]

Soleo Organics Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-01-20

NDC 11045-0303-3 [11045030303]

Soleo Organics Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-01-20

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE223 mg/g

OpenFDA Data

SPL SET ID:59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b
Manufacturer
UNII

NDC Crossover Matching brand name "Soleo Organics Sunscreen" or generic name "Zinc Oxide"

NDCBrand NameGeneric Name
11045-0303Soleo Organics SunscreenSoleo Organics Sunscreen
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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