NDC 69435-1905

XXL Sun Block SPF 50

Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate Cream

XXL Sun Block SPF 50 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Peer Pharma Ltd.. The primary component is Octocrylene; Octisalate; Avobenzone; Homosalate; Oxybenzone.

• Product ID: 69435-1905_91e7bee2-7de8-542f-e053-2995a90aec4f
• NDC: 69435-1905
• Product Type: Human Otc Drug
• Proprietary Name: XXL Sun Block SPF 50
• Generic Name: Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate Cream
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-09-06
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Peer Pharma Ltd.
• Substance Name: OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE
• Active Ingredient Strength: 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69435-1905-1

100 mL in 1 CONTAINER (69435-1905-1)

• Marketing Start Date: 2019-09-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69435-1905-1 [69435190501]

XXL Sun Block SPF 50 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-09-06

Drug Details

Active Ingredients

Ingredient	Strength
OCTOCRYLENE	4 g/100mL

OpenFDA Data

• SPL SET ID: 91e7d23d-2bea-545b-e053-2995a90a75e4
• Manufacturer:
  • Peer Pharma Ltd.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

NDC Crossover Matching brand name "XXL Sun Block SPF 50" or generic name "Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate Cream"

NDC	Brand Name	Generic Name
69435-1804	XXL Sun Block SPF 50	Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate, Titanium Dioxide cream
69435-1905	XXL Sun Block SPF 50	Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream
69435-1606	Mineralium Hdra Source Moisturizing Protector SPF 25	Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream
69435-1604	Spa Pharma Olive Oil Moisturizing Cream	Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream
69435-1906	XXL Demi Make Up SPF 50	Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream