NDC 14783-901

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50

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

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Ventura International Ltd. The primary component is Octinoxate; Titanium Dioxide; Homosalate; Octisalate; Oxybenzone; Zinc Oxide.

Product ID14783-901_bfa9d95a-48e7-45c6-ab23-b1f5d92147c3
NDC14783-901
Product TypeHuman Otc Drug
Proprietary NameLBEL DEFENSE 365 DAILY PROTECTIVE SPF 50
Generic NameOctinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, And Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2014-10-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameVentura International LTD
Substance NameOCTINOXATE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OXYBENZONE; 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 14783-901-02

1 BOTTLE in 1 BOX (14783-901-02) > 30 mL in 1 BOTTLE (14783-901-01)
Marketing Start Date2014-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14783-901-01 [14783090101]

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-14

NDC 14783-901-02 [14783090102]

LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE.07 g/mL

OpenFDA Data

SPL SET ID:1d9cc3ae-9a95-459b-ad05-df1e877d25fa
Manufacturer
UNII

NDC Crossover Matching brand name "LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50" or generic name "Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, And Zinc Oxide"

NDCBrand NameGeneric Name
14783-901LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide
13537-901LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide

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