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 ID69039-559_2a2eae98-efeb-4b3e-9ce7-6ad972364280
NDC69039-559
Product TypeHuman Otc Drug
Proprietary NameSunBum SPF 50
Generic NameOctisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00%
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2011-02-10
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSun Bum
Substance NameOCTISALATE; OCTINOXATE; OXYBENZONE; ZINC OXIDE
Active Ingredient Strength5 g/100mL; g/100mL; g/100mL; 1/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69039-559-01

1 JAR in 1 CARTON (69039-559-01) > 30 mL in 1 JAR
Marketing Start Date2011-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69039-559-01 [69039055901]

SunBum SPF 50 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-02-10
Marketing End Date2018-08-31
Inactivation Date2020-01-31
Reactivation Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
OCTISALATE5 g/100mL

OpenFDA Data

SPL SET ID:4f1432b2-b694-4a45-be38-ff44c8ca464d
Manufacturer
UNII

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

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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