NDC 13537-402

LBEL UV DEFENSE 365

Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide

LBEL UV DEFENSE 365 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Ventura Corporation Ltd. (san Juan, P.r). The primary component is Homosalate; Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide; Zinc Oxide.

Product ID13537-402_38b1a1b0-a33d-404c-8214-b9cbf57a478c
NDC13537-402
Product TypeHuman Otc Drug
Proprietary NameLBEL UV DEFENSE 365
Generic NameHomosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2011-08-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameVentura Corporation Ltd. (San Juan, P.R)
Substance NameHOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active Ingredient Strength0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 13537-402-05

1 mL in 1 PACKET (13537-402-05)
Marketing Start Date2011-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13537-402-02 [13537040202]

LBEL UV DEFENSE 365 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-10-29

NDC 13537-402-01 [13537040201]

LBEL UV DEFENSE 365 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-29

NDC 13537-402-04 [13537040204]

LBEL UV DEFENSE 365 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-10-29

NDC 13537-402-05 [13537040205]

LBEL UV DEFENSE 365 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-29
Inactivation Date2019-10-29

NDC 13537-402-03 [13537040203]

LBEL UV DEFENSE 365 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-29

Drug Details

Active Ingredients

IngredientStrength
HOMOSALATE.05 g/mL

OpenFDA Data

SPL SET ID:0873d6a1-55df-415e-8f95-2d08ef7ee84f
Manufacturer
UNII

NDC Crossover Matching brand name "LBEL UV DEFENSE 365" or generic name "Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide"

NDCBrand NameGeneric Name
13537-402LBEL UV DEFENSE 365Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
14783-094LBEL UV DEFENSE 365Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
13537-177LBEL DEFENSE 365 oil-free daily protective facial SPF 50Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide
14783-992LBEL DEFENSE 365 oil-free daily protective facial SPF 50Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide

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