NDC 52854-016

Reef Safe SPF 15

Homosalate, Octinoxate, Oxybenzone And Octisalate

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

• Product ID: 52854-016_66f87097-918f-4ef3-a3d2-0d0c78319816
• NDC: 52854-016
• Product Type: Human Otc Drug
• Proprietary Name: Reef Safe SPF 15
• Generic Name: Homosalate, Octinoxate, Oxybenzone And Octisalate
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-09-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Tropical Seas, Inc.
• Substance Name: HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE
• Active Ingredient Strength: 10 g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52854-016-01

250 mL in 1 BOTTLE, PLASTIC (52854-016-01)

• Marketing Start Date: 2009-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52854-016-01 [52854001601]

Reef Safe SPF 15 SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-09-01

Drug Details

Active Ingredients

Ingredient	Strength
HOMOSALATE	10 g/100mL

OpenFDA Data

• SPL SET ID: d4dd1b7d-cff6-4bba-95cf-9f8ac836935d
• Manufacturer:
  • Tropical Seas, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • V06SV4M95S
  • 4Y5P7MUD51

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

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
52854-531	Reef Kids SPF 30	homosalate, octinoxate, oxybenzone and octisalate
52854-032	Reef Safe SPF 30	homosalate, octinoxate, oxybenzone and octisalate