Home NDC 87461-904 Botnia Gentle Sun SPF 30
Product NDC 87461-904
11-digit product format 874610904
Labeler code 87461
Product ID 87461-904_4c1e721a-a8f5-db1b-e063-6294a90a0a26
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Botnia, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-19
Substance ZINC OXIDE
Active strength 180 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Botnia Gentle Sun SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 180 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 87461-904-00 Botnia Gentle Sun SPF 30 50 mL in 1 TUBE CREAM 50 1 87461-904-00 Botnia Gentle Sun SPF 30 1 in 1 BOX CREAM 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 Units Marketing start Sample Exclude flag Status 87461-904-00 87461090400 1 TUBE in 1 BOX (87461-904-00) / 50 mL in 1 TUBE 1 tube 2026-01-19 No No Current