NDC 52854-015

Reef Safe SPF 15

Octinoxate,octisalate, And Oxybenzone

Reef Safe SPF 15 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Tropical Seas, Inc.. The primary component is Octinoxate; Octisalate; Oxybenzone.

• Product ID: 52854-015_9e65f32d-ab16-404b-e053-2995a90adc1b
• NDC: 52854-015
• Product Type: Human Otc Drug
• Proprietary Name: Reef Safe SPF 15
• Generic Name: Octinoxate,octisalate, And Oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 1995-01-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Tropical Seas, Inc.
• Substance Name: OCTINOXATE; OCTISALATE; OXYBENZONE
• Active Ingredient Strength: 7 g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52854-015-01

120 mL in 1 BOTTLE, PLASTIC (52854-015-01)

• Marketing Start Date: 1995-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52854-015-01 [52854001501]

Reef Safe SPF 15 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 1995-01-01

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7 g/100mL

OpenFDA Data

• SPL SET ID: dc900552-df18-403e-a90d-c5f9aed7d2ef
• Manufacturer:
  • Tropical Seas, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "Reef Safe SPF 15" or generic name "Octinoxate,octisalate, And Oxybenzone"

NDC	Brand Name	Generic Name
52854-015	Reef Safe SPF 15	octinoxate,octisalate, and oxybenzone
52854-016	Reef Safe SPF 15	homosalate, octinoxate, oxybenzone and octisalate
52854-030	Reef Safe SPF 30	octinoxate,octisalate, and oxybenzone