NDC 69039-209

SPF 50 Signature High Performance Sunscreen

Octinoxate, Octisalate, Octocrylene, Zinc Oxide

SPF 50 Signature High Performance Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Sun Bum, Llc. The primary component is Octinoxate; Octisalate; Octocrylene; Zinc Oxide.

• Product ID: 69039-209_7e06de3c-15c6-2106-e053-2a91aa0a16ab
• NDC: 69039-209
• Product Type: Human Otc Drug
• Proprietary Name: SPF 50 Signature High Performance Sunscreen
• Generic Name: Octinoxate, Octisalate, Octocrylene, Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-08-25
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Sun Bum, LLC
• Substance Name: OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
• Active Ingredient Strength: 75 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69039-209-01

1 BOTTLE in 1 BOX (69039-209-01) > 88 mL in 1 BOTTLE

• Marketing Start Date: 2017-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69039-209-01 [69039020901]

SPF 50 Signature High Performance Sunscreen LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-08-25

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	75 mg/mL

OpenFDA Data

• SPL SET ID: b3fbbbf6-e56d-4ea8-8e76-898105104f15
• Manufacturer:
  • Sun Bum, LLC
• UNII:
  • SOI2LOH54Z
  • 4X49Y0596W
  • 5A68WGF6WM
  • 4Y5P7MUD51

NDC Crossover Matching brand name "SPF 50 Signature High Performance Sunscreen" or generic name "Octinoxate, Octisalate, Octocrylene, Zinc Oxide"

NDC	Brand Name	Generic Name
69039-209	SPF 50 Signature High Performance Sunscreen	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
69039-228	SPF 50 Signature High Performance Sunscreen	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
69039-252	SPF 50 Signature High Performance Sunscreen	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
72085-147	Sea Star Sparkle SPF-50 MANGO-TANGO	Octinoxate, Octisalate, Octocrylene, Zinc Oxide
72085-148	Sea Star Sparkle SPF-50 PARTY CAKE	Octinoxate, Octisalate, Octocrylene, Zinc Oxide
72085-149	Sea Star Sparkle SPF-50 VERY BERRY	Octinoxate, Octisalate, Octocrylene, Zinc Oxide
69039-251	Sun Bum Clear Zinc SPF50 Sunscreen	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE