Home NDC 85528-592 Sunstation Sport Sunscreen SPF 30
Product NDC 85528-592
11-digit product format 855280592
Labeler code 85528
Product ID 85528-592_33837cbb-2aab-a894-e063-6394a90acdda
Type HUMAN OTC DRUG
Nonproprietary name OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Impact Melanoma Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-19
Substance OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength 50; 80; 80 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 Sunstation Sport Sunscreen SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 50 mg/mL OCTOCRYLENE 80 mg/mL ZINC OXIDE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup 5A68WGF6WM 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 85528-592-00 Sunstation Sport Sunscreen SPF 30 1000 mL in 1 BOTTLE CREAM 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85528-592 SUNSTATION SPORT SUNSCREEN SPF 30 (OCTISALATE, OCTOCRYLENE, ZINC OXIDE) CREAM [IMPACT MELANOMA INC] 1 Current NDC, 1 package rows 20250426_ba78aa73-a25b-4a8e-99b2-9262bb9a7d27.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 85528-592-00 85528059200 1000 mL in 1 BOTTLE (85528-592-00) 1000 ml 2025-03-19 No No Current