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 ID69039-557_ee004f19-f5ce-4f7e-8280-6de4a738f3ac
NDC69039-557
Product TypeHuman Otc Drug
Proprietary NameSunBum SPF 30
Generic NameOctinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2015-07-23
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSun Bum
Substance NameOCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active Ingredient Strength8 g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69039-557-03

88 mL in 1 BOTTLE (69039-557-03)
Marketing Start Date2015-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69039-557-03 [69039055703]

SunBum SPF 30 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-23
Marketing End Date2018-08-31
Inactivation Date2020-01-31
Reactivation Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.5 g/100mL

OpenFDA Data

SPL SET ID:1bbfce71-7236-4b67-a3d1-3e5757607052
Manufacturer
UNII

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

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

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