NDC 43455-0001

LBEL DEFENSE 365 Daily Protective Facial SPF 50

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

LBEL DEFENSE 365 Daily Protective Facial 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 Homosalate; Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide; Zinc Oxide.

• Product ID: 43455-0001_c028cd57-f5e6-4dc6-9640-bee5283e1051
• NDC: 43455-0001
• Product Type: Human Otc Drug
• Proprietary Name: LBEL DEFENSE 365 Daily Protective Facial SPF 50
• Generic Name: Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-03-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Ventura International, LTD
• Substance Name: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 43455-0001-0

1 mL in 1 POUCH (43455-0001-0)

• Marketing Start Date: 2012-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43455-0001-1 [43455000101]

LBEL DEFENSE 365 Daily Protective Facial SPF 50 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-03-28
• Inactivation Date: 2019-11-13

NDC 43455-0001-2 [43455000102]

LBEL DEFENSE 365 Daily Protective Facial SPF 50 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-03-28
• Inactivation Date: 2019-11-13

NDC 43455-0001-0 [43455000100]

LBEL DEFENSE 365 Daily Protective Facial SPF 50 LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-03-28
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
HOMOSALATE	5 mL/100mL

OpenFDA Data

• SPL SET ID: 297ba415-f131-4dd3-9457-ef5382389683
• Manufacturer:
  • Ventura International, LTD
• UNII:
  • V06SV4M95S
  • 15FIX9V2JP
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51
  • SOI2LOH54Z

NDC Crossover Matching brand name "LBEL DEFENSE 365 Daily Protective Facial SPF 50" or generic name "Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide"

NDC	Brand Name	Generic Name
13537-901	LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50	Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide
43455-0001	LBEL DEFENSE 365 Daily Protective Facial SPF 50	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
43596-0001	LBEL DEFENSE 365 Daily Protective Facial SPF 50	HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE