NDC 69039-557

SunBum SPF 30

Octinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00%

SunBum SPF 30 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Sun Bum. The primary component is Octinoxate; Octocrylene; Zinc Oxide.

• Product ID: 69039-557_ee004f19-f5ce-4f7e-8280-6de4a738f3ac
• NDC: 69039-557
• Product Type: Human Otc Drug
• Proprietary Name: SunBum SPF 30
• Generic Name: Octinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00%
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-07-23
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Sun Bum
• Substance Name: OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
• Active Ingredient Strength: 8 g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69039-557-03

88 mL in 1 BOTTLE (69039-557-03)

• Marketing Start Date: 2015-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69039-557-03 [69039055703]

SunBum SPF 30 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-07-23
• 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: 1bbfce71-7236-4b67-a3d1-3e5757607052
• Manufacturer:
  • Sun Bum
• UNII:
  • SOI2LOH54Z
  • 5A68WGF6WM
  • 4Y5P7MUD51

NDC Crossover Matching brand name "SunBum SPF 30" or generic name "Octinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00%"

NDC	Brand Name	Generic Name
69039-552	SunBum SPF 30	Avobenzone 3.00% Homosalate 5.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 4.00%
69039-554	SunBum SPF 30	Avobenzone 3.00% Homosalate 10.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 3.00%
69039-557	SunBum SPF 30	Octinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00%