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 ID69039-558_1b0c02e2-f973-4933-8da0-3eb0b5e00a48
NDC69039-558
Product TypeHuman Otc Drug
Proprietary NameSunBum SPF 50
Generic NameOctinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2015-01-22
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSun Bum
Substance NameOCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active Ingredient Strength8 g/100mL; g/100mL; g/100mL; 1/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69039-558-03

88 mL in 1 BOTTLE (69039-558-03)
Marketing Start Date2015-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69039-558-03 [69039055803]

SunBum SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-01-22
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:3bb495f0-a500-44ed-8358-c4fe6c1fdbb1
Manufacturer
UNII

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

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

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