NDC 52854-400

Reef Safe SPF 40

Octocrylene, Octisalate, Oxybenzone, And Avobenzone

Reef Safe SPF 40 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Tropical Seas, Inc.. The primary component is Octocrylene; Octisalate; Oxybenzone; Avobenzone.

• Product ID: 52854-400_6ff9e7dd-afe2-40b5-9b41-ec363b621142
• NDC: 52854-400
• Product Type: Human Otc Drug
• Proprietary Name: Reef Safe SPF 40
• Generic Name: Octocrylene, Octisalate, Oxybenzone, And Avobenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-07-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Tropical Seas, Inc.
• Substance Name: OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE
• Active Ingredient Strength: 4 g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52854-400-01

120 mL in 1 BOTTLE, PLASTIC (52854-400-01)

• Marketing Start Date: 2012-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52854-400-01 [52854040001]

Reef Safe SPF 40 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01
• Marketing End Date: 2020-01-01

Drug Details

Active Ingredients

Ingredient	Strength
OCTOCRYLENE	3.5 g/100mL

OpenFDA Data

• SPL SET ID: c09ed8c5-022e-42b4-8997-f2eec05bada1
• Manufacturer:
  • Tropical Seas, Inc.
• UNII:
  • G63QQF2NOX
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 5A68WGF6WM

NDC Crossover Matching brand name "Reef Safe SPF 40" or generic name "Octocrylene, Octisalate, Oxybenzone, And Avobenzone"

NDC	Brand Name	Generic Name
52854-400	Reef Safe SPF 40	octocrylene, octisalate, oxybenzone, and avobenzone
52854-230	Native Tan SPF 30	octocrylene, octisalate, oxybenzone, and avobenzone
52854-240	Native Tan SPF 40	octocrylene, octisalate, oxybenzone, and avobenzone
52854-250	Native Tan SPF 50	octocrylene, octisalate, oxybenzone, and avobenzone
52854-255	Native Tan SPF 50	octocrylene, octisalate, oxybenzone, and avobenzone
52854-550	Reef Babies SPF 50	octocrylene, octisalate, oxybenzone, and avobenzone
52854-530	Reef Kids SPF 30	octocrylene, octisalate, oxybenzone, and avobenzone
52854-540	Reef Kids SPF 40	octocrylene, octisalate, oxybenzone, and avobenzone
52854-300	Reef Safe SPF 30	octocrylene, octisalate, oxybenzone, and avobenzone
52854-500	Reef Safe SPF 50	octocrylene, octisalate, oxybenzone, and avobenzone