NDC 52854-045

Reef Safe SPF 45

Octocrylene, Octinoxate, Oxybenzone, Homosalate And Octisalate

Reef Safe SPF 45 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Tropical Seas, Inc.. The primary component is Octocrylene; Octinoxate; Oxybenzone; Homosalate; Octisalate.

• Product ID: 52854-045_1c492a85-2570-4316-839f-99a73041f003
• NDC: 52854-045
• Product Type: Human Otc Drug
• Proprietary Name: Reef Safe SPF 45
• Generic Name: Octocrylene, Octinoxate, Oxybenzone, Homosalate And Octisalate
• 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: OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE
• Active Ingredient Strength: 8 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52854-045-01

120 mL in 1 BOTTLE, PLASTIC (52854-045-01)

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

NDC SPL Data Element Entries

NDC 52854-045-01 [52854004501]

Reef Safe SPF 45 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
OCTOCRYLENE	8 g/100mL

OpenFDA Data

• SPL SET ID: 37f7d4e9-34c9-460a-a28b-ce685e7b3b0a
• Manufacturer:
  • Tropical Seas, Inc.
• UNII:
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM
  • 4Y5P7MUD51
  • V06SV4M95S

NDC Crossover Matching brand name "Reef Safe SPF 45" or generic name "Octocrylene, Octinoxate, Oxybenzone, Homosalate And Octisalate"

NDC	Brand Name	Generic Name
52854-045	Reef Safe SPF 45	octocrylene, octinoxate, oxybenzone, homosalate and octisalate
52854-046	Reef Safe SPF 45	homosalate, octocrylene, octinoxate, oxybenzone and octisalate
52854-945	Land Shark SPF 45	octocrylene, octinoxate, oxybenzone, homosalate and octisalate