Home NDC 84259-475 SUN CONTROL BROAD SPECTRUM SPF 30
Product NDC 84259-475
11-digit product format 842590475
Labeler code 84259
Product ID 84259-475_161fc0cf-491c-2123-e063-6294a90aaa7a
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler SKINPLAN.US LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-22
Substance HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength 70; 50; 60 mg/mL; mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 SUN CONTROL BROAD SPECTRUM SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 70 mg/mL OCTISALATE 50 mg/mL ZINC OXIDE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84259-475-00 SUN CONTROL BROAD SPECTRUM SPF 30 100 mL in 1 TUBE CREAM 100 1 84259-475-00 SUN CONTROL BROAD SPECTRUM SPF 30 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84259-475 SUN CONTROL BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SKINPLAN.US LLC] 1 Current NDC, 2 package rows 20240423_8e34a343-7253-469f-9973-076a7ae26cbc.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 84259-475-00 84259047500 1 TUBE in 1 BOX (84259-475-00) / 100 mL in 1 TUBE 1 tube 2024-04-22 No No Current