NDC 71496-0003

Waterful Sun

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Waterful Sun is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Ari&j Inc. The primary component is Octinoxate; Octocrylene; Octisalate; Avobenzone.

• Product ID: 71496-0003_5326ae14-eb98-1351-e054-00144ff8d46c
• NDC: 71496-0003
• Product Type: Human Otc Drug
• Proprietary Name: Waterful Sun
• Generic Name: Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-06-30
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: ARI&J Inc
• Substance Name: OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
• Active Ingredient Strength: 7 g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 71496-0003-1

50 mL in 1 TUBE (71496-0003-1)

• Marketing Start Date: 2017-06-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71496-0003-1 [71496000301]

Waterful Sun GEL

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-30
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7 g/100mL

OpenFDA Data

• SPL SET ID: 5326ae14-eb97-1351-e054-00144ff8d46c
• Manufacturer:
  • ARI&J Inc
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM
  • 4Y5P7MUD51