NDC 69039-559

SunBum SPF 50

Octisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00%

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

• Product ID: 69039-559_2a2eae98-efeb-4b3e-9ce7-6ad972364280
• NDC: 69039-559
• Product Type: Human Otc Drug
• Proprietary Name: SunBum SPF 50
• Generic Name: Octisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-02-10
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Sun Bum
• Substance Name: OCTISALATE; OCTINOXATE; OXYBENZONE; ZINC OXIDE
• Active Ingredient Strength: 5 g/100mL; g/100mL; g/100mL; 1/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69039-559-01

1 JAR in 1 CARTON (69039-559-01) > 30 mL in 1 JAR

• Marketing Start Date: 2011-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69039-559-01 [69039055901]

SunBum SPF 50 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-02-10
• Marketing End Date: 2018-08-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-27

Drug Details

Active Ingredients

Ingredient	Strength
OCTISALATE	5 g/100mL

OpenFDA Data

• SPL SET ID: 4f1432b2-b694-4a45-be38-ff44c8ca464d
• Manufacturer:
  • Sun Bum
• UNII:
  • SOI2LOH54Z
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "SunBum SPF 50" or generic name "Octisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00%"

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%