NDC 69039-554

SunBum SPF 30

Avobenzone 3.00% Homosalate 10.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 3.00%

SunBum SPF 30 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Sun Bum. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone.

Product ID69039-554_323811cf-264a-4066-be46-5706d56ab142
NDC69039-554
Product TypeHuman Otc Drug
Proprietary NameSunBum SPF 30
Generic NameAvobenzone 3.00% Homosalate 10.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 3.00%
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2011-02-10
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSun Bum
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active Ingredient Strength3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69039-554-05

177 mL in 1 CAN (69039-554-05)
Marketing Start Date2014-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69039-554-05 [69039055405]

SunBum SPF 30 SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-01-12
Marketing End Date2018-08-31
Inactivation Date2020-01-31
Reactivation Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE3 g/100mL

OpenFDA Data

SPL SET ID:697bf8ee-541a-44f4-ab0f-d2047f6e7eb0
Manufacturer
UNII

NDC Crossover Matching brand name "SunBum SPF 30" or generic name "Avobenzone 3.00% Homosalate 10.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 3.00%"

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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