NDC 51191-3016

SPF 25 UVA/UVB

Ensulizole, Oxybenzone, Avobenzone, Octocrylene

SPF 25 UVA/UVB is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Multaler Et Cie S.a.s.. The primary component is Octocrylene; Oxybenzone; Avobenzone; Ensulizole.

• Product ID: 51191-3016_6f7831d9-edcc-4f52-94f9-b0172368713b
• NDC: 51191-3016
• Product Type: Human Otc Drug
• Proprietary Name: SPF 25 UVA/UVB
• Generic Name: Ensulizole, Oxybenzone, Avobenzone, Octocrylene
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-04-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: MULTALER ET CIE S.A.S.
• Substance Name: OCTOCRYLENE; OXYBENZONE; AVOBENZONE; ENSULIZOLE
• Active Ingredient Strength: 6 g/100g; g/100g; g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51191-3016-1

50 g in 1 TUBE (51191-3016-1)

• Marketing Start Date: 2013-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51191-3016-1 [51191301601]

SPF 25 UVA/UVB CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-04-15

Drug Details

Active Ingredients

Ingredient	Strength
OCTOCRYLENE	6 g/100g

OpenFDA Data

• SPL SET ID: 241543c1-5306-4933-bda5-a4ca28fe1adb
• Manufacturer:
  • MULTALER ET CIE S.A.S.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 5A68WGF6WM
  • 9YQ9DI1W42

NDC Crossover Matching brand name "SPF 25 UVA/UVB" or generic name "Ensulizole, Oxybenzone, Avobenzone, Octocrylene"

NDC	Brand Name	Generic Name
51191-3016	SPF 25 UVA/UVB	ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE
51191-3015	SPF 50 UVA/UVB	ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE