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 ID: 59958-408_3c4942ec-463f-48b7-a342-24d9f6a5148c
• NDC: 59958-408
• Product Type: Human Otc Drug
• Proprietary Name: Cream Oil Sunscreen
• Generic Name: Zinc Oxide, Titanium Dioxide Sunscreen
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-04
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Owen Biosciences, Inc.
• Substance Name: ZINC OXIDE; TITANIUM DIOXIDE
• Active Ingredient Strength: 21 g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59958-408-02

1 TUBE in 1 CARTON (59958-408-02) > 50 g in 1 TUBE (59958-408-01)

• Marketing Start Date: 2020-04-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59958-408-01 [59958040801]

Cream Oil Sunscreen CREAM

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-04

NDC 59958-408-02 [59958040802]

Cream Oil Sunscreen CREAM

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-04

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	21 g/100g

OpenFDA Data

• SPL SET ID: b2ccdfea-1c27-42af-b9d8-752e9f91ae87
• Manufacturer:
  • Owen Biosciences, Inc.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z

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

NDC	Brand Name	Generic Name
59958-408	Cream Oil Sunscreen	Zinc Oxide, Titanium Dioxide Sunscreen
72043-2600	EltaMD UV Active	zinc oxide, titanium dioxide sunscreen
60232-1830	Image Prevention Refiner Primer SPF50	Zinc oxide, titanium dioxide sunscreen