NDC 69039-550

Sun Bum 50

Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 2.75% Oxybenzone 6.00%

Sun Bum 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Sun Bum Llc. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone.

Product ID69039-550_b079c52d-f86d-4799-bc1d-9ceb4fe34644
NDC69039-550
Product TypeHuman Otc Drug
Proprietary NameSun Bum 50
Generic NameAvobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 2.75% Oxybenzone 6.00%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2012-02-23
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSun Bum LLC
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active Ingredient Strength3 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69039-550-05

177 mL in 1 TUBE (69039-550-05)
Marketing Start Date2014-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69039-550-06 [69039055006]

Sun Bum 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-23
Marketing End Date2018-08-31
Inactivation Date2020-01-31
Reactivation Date2020-02-26

NDC 69039-550-05 [69039055005]

Sun Bum 50 LOTION
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 Date2020-02-26

NDC 69039-550-03 [69039055003]

Sun Bum 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-03-12
Marketing End Date2018-08-31
Inactivation Date2020-01-31
Reactivation Date2020-02-26

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE3 mg/100mL

OpenFDA Data

SPL SET ID:9b174cd6-3c1e-41e2-863f-9f575fce5496
Manufacturer
UNII

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