NDC 43419-418

IOPE UV DEFENSE SUN PROTECTOR EX

Avobenzone, Homosalate, Octocrylene, Octisalate Lotion

IOPE UV DEFENSE SUN PROTECTOR EX is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Amorepacific Corporation. The primary component is Avobenzone; Octisalate; Homosalate; Octocrylene.

• Product ID: 43419-418_a085c09f-9d9c-0e5f-e053-2a95a90aae9b
• NDC: 43419-418
• Product Type: Human Otc Drug
• Proprietary Name: IOPE UV DEFENSE SUN PROTECTOR EX
• Generic Name: Avobenzone, Homosalate, Octocrylene, Octisalate Lotion
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-04-27
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Amorepacific Corporation
• Substance Name: AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
• Active Ingredient Strength: 2 mg/60mL; mg/60mL; mg/60mL; mg/60mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43419-418-18

1 TUBE in 1 CARTON (43419-418-18) > 60 mL in 1 TUBE

• Marketing Start Date: 2020-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43419-418-18 [43419041818]

IOPE UV DEFENSE SUN PROTECTOR EX LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-04-27

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	1.5 mg/60mL

OpenFDA Data

• SPL SET ID: a085c0d6-2653-6364-e053-2995a90a02b5
• Manufacturer:
  • Amorepacific Corporation
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

NDC Crossover Matching brand name "IOPE UV DEFENSE SUN PROTECTOR EX" or generic name "Avobenzone, Homosalate, Octocrylene, Octisalate Lotion"

NDC	Brand Name	Generic Name
43419-418	IOPE UV DEFENSE SUN PROTECTOR EX	Avobenzone, Homosalate, Octocrylene, Octisalate Lotion
43419-419	IOPE UV MEN DEFENSE SUN PROTECTOR EX	Avobenzone, Homosalate, Octocrylene, Octisalate Lotion