NDC 63645-165

Sunfrog Ultra SPF 30 Lip Balm

Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly

Sunfrog Ultra SPF 30 Lip Balm is a Topical Stick in the Human Otc Drug category. It is labeled and distributed by Oralabs. The primary component is Octinoxate; Oxybenzone; Petrolatum; Octocrylene; Octisalate.

• Product ID: 63645-165_61299626-bf60-40e8-a2d3-4d4a99d8d15c
• NDC: 63645-165
• Product Type: Human Otc Drug
• Proprietary Name: Sunfrog Ultra SPF 30 Lip Balm
• Generic Name: Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
• Dosage Form: Stick
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-29
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: OraLabs
• Substance Name: OCTINOXATE; OXYBENZONE; PETROLATUM; OCTOCRYLENE; OCTISALATE
• Active Ingredient Strength: 8 mg/g; mg/g; mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63645-165-01

1 g in 1 CONTAINER (63645-165-01)

• Marketing Start Date: 2017-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63645-165-01 [63645016501]

Sunfrog Ultra SPF 30 Lip Balm STICK

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-29

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7.5 mg/g

OpenFDA Data

• SPL SET ID: 61299626-bf60-40e8-a2d3-4d4a99d8d15c
• Manufacturer:
  • OraLabs
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • 4Y5P7MUD51
  • 4T6H12BN9U