NDC 59958-408

Cream Oil Sunscreen

Zinc Oxide, Titanium Dioxide Sunscreen

Cream Oil Sunscreen is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Owen Biosciences, Inc.. The primary component is Zinc Oxide; Titanium Dioxide.

Product ID59958-408_3c4942ec-463f-48b7-a342-24d9f6a5148c
NDC59958-408
Product TypeHuman Otc Drug
Proprietary NameCream Oil Sunscreen
Generic NameZinc Oxide, Titanium Dioxide Sunscreen
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2020-04-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameOwen Biosciences, Inc.
Substance NameZINC OXIDE; TITANIUM DIOXIDE
Active Ingredient Strength21 g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59958-408-02

1 TUBE in 1 CARTON (59958-408-02) > 50 g in 1 TUBE (59958-408-01)
Marketing Start Date2020-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59958-408-01 [59958040801]

Cream Oil Sunscreen CREAM
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-04

NDC 59958-408-02 [59958040802]

Cream Oil Sunscreen CREAM
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-04

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE21 g/100g

OpenFDA Data

SPL SET ID:b2ccdfea-1c27-42af-b9d8-752e9f91ae87
Manufacturer
UNII

NDC Crossover Matching brand name "Cream Oil Sunscreen" or generic name "Zinc Oxide, Titanium Dioxide Sunscreen"

NDCBrand NameGeneric Name
59958-408Cream Oil SunscreenZinc Oxide, Titanium Dioxide Sunscreen
72043-2600EltaMD UV Activezinc oxide, titanium dioxide sunscreen
60232-1830Image Prevention Refiner Primer SPF50Zinc oxide, titanium dioxide sunscreen

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