Home NDC 84489-100 SPF 50 Florida Sun Defense
Product NDC 84489-100
11-digit product format 844890100
Labeler code 84489
Product ID 84489-100_47c147a9-c4f5-ab82-e063-6394a90aaa5c
Type HUMAN OTC DRUG
Nonproprietary name homosalate, octisalate, octocrylene
Dosage form OIL
Route TOPICAL
Labeler Naples Soap Company, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-03
Substance OCTOCRYLENE; HOMOSALATE; OCTISALATE
Active strength 10; 10; 5 g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SPF 50 Florida Sun Defense
Brand name suffix Broad Spectrum SPF 50 Sunscreen Body Oil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 10 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84489-100-34 SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil 100 mL in 1 BOTTLE, PUMP OIL 100 1 84489-100-34 SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil 1 in 1 CARTON OIL 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84489-100-34 84489010034 1 BOTTLE, PUMP in 1 CARTON (84489-100-34) / 100 mL in 1 BOTTLE, PUMP 2025-07-03 No No Current