NDC 69039-558

SunBum SPF 50

Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00%

SunBum SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Sun Bum. The primary component is Octinoxate; Octisalate; Octocrylene; Zinc Oxide.

• Product ID: 69039-558_1b0c02e2-f973-4933-8da0-3eb0b5e00a48
• NDC: 69039-558
• Product Type: Human Otc Drug
• Proprietary Name: SunBum SPF 50
• Generic Name: Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00%
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-01-22
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Sun Bum
• Substance Name: OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
• Active Ingredient Strength: 8 g/100mL; g/100mL; g/100mL; 1/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69039-558-03

88 mL in 1 BOTTLE (69039-558-03)

• Marketing Start Date: 2015-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69039-558-03 [69039055803]

SunBum SPF 50 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-01-22
• Marketing End Date: 2018-08-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-27

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7.5 g/100mL

OpenFDA Data

• SPL SET ID: 3bb495f0-a500-44ed-8358-c4fe6c1fdbb1
• Manufacturer:
  • Sun Bum
• UNII:
  • SOI2LOH54Z
  • 4X49Y0596W
  • 5A68WGF6WM
  • 4Y5P7MUD51

NDC Crossover Matching brand name "SunBum SPF 50" or generic name "Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00%"

NDC	Brand Name	Generic Name
69039-558	SunBum SPF 50	Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00%
69039-559	SunBum SPF 50	Octisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00%
69039-560	SunBum SPF 50	Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.75% Oxybenzone 6.00%