Home NDC 84562-509 Tan De Soleil Orange Tanning Balm SPF 6
Product NDC 84562-509
11-digit product format 845620509
Labeler code 84562
Product ID 84562-509_1d6fdd9f-1b62-095b-e063-6394a90ac467
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE
Dosage form OIL
Route TOPICAL
Labeler TANNING CLUB, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
Substance HOMOSALATE; OCTISALATE
Active strength 30; 40 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Tan De Soleil Orange Tanning Balm SPF 6
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 30 mg/mL OCTISALATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 84562-509-00 Tan De Soleil Orange Tanning Balm SPF 6 100 mL in 1 TUBE OIL 100 1 84562-509-00 Tan De Soleil Orange Tanning Balm SPF 6 1 in 1 BOX OIL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84562-509 TAN DE SOLEIL ORANGE TANNING BALM SPF 6 (HOMOSALATE, OCTISALATE) OIL [TANNING CLUB, LLC] 1 Current NDC, 2 package rows 20240718_5343f359-6074-467c-99bb-f08a7ca2df41.zip
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 Units Marketing start Sample Exclude flag Status 84562-509-00 84562050900 1 TUBE in 1 BOX (84562-509-00) / 100 mL in 1 TUBE 1 tube 2024-07-01 No No Current