NDC 69039-553

SunBum SPF 70

Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%

SunBum SPF 70 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Sun Bum. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone.

• Product ID: 69039-553_a63b743c-2362-4d3b-b8fc-2887e520617e
• NDC: 69039-553
• Product Type: Human Otc Drug
• Proprietary Name: SunBum SPF 70
• Generic Name: Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%
• Dosage Form: Lotion
• 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: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69039-553-06

237 mL in 1 TUBE (69039-553-06)

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

NDC SPL Data Element Entries

NDC 69039-553-05 [69039055305]

SunBum SPF 70 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-01-12
• Marketing End Date: 2018-08-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-26

NDC 69039-553-03 [69039055303]

SunBum SPF 70 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-03-02
• Marketing End Date: 2018-08-31
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-26

NDC 69039-553-06 [69039055306]

SunBum SPF 70 LOTION

• 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: 2020-02-26

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	3 g/100mL

OpenFDA Data

• SPL SET ID: d1d24adf-f402-45ff-b38b-29293b23263d
• Manufacturer:
  • Sun Bum
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

NDC Crossover Matching brand name "SunBum SPF 70" or generic name "Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%"

NDC	Brand Name	Generic Name
69039-553	SunBum SPF 70	Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%
69039-556	SunBum SPF 70	Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 4% Oxybenzone 6%
11822-7803	Ultimate Sheer Sunscreen SPF 70	Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%
55301-777	Ultimate Sheer Sunscreen SPF 70	Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%
63868-781	Ultimate Sheer Sunscreen SPF 70	Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00%