Home NDC 59958-601 FHF Elevated Shade 100% Mineral Sunscreen
Product NDC 59958-601
11-digit product format 599580601
Labeler code 59958
Product ID 59958-601_258f9ba3-0149-a6bd-e063-6394a90add55
Type HUMAN OTC DRUG
Nonproprietary name sunscreen
Dosage form LOTION
Route TOPICAL
Labeler Owen Biosciences Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-21
Substance ZINC OXIDE
Active strength .21 g/g
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 FHF Elevated Shade 100% Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE .21 g/g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59958-601-01 FHF Elevated Shade 100% Mineral Sunscreen 50 g in 1 BOTTLE LOTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-601 FHF ELEVATED SHADE 100% MINERAL SUNSCREEN (SUNSCREEN) LOTION [OWEN BIOSCIENCES INC] 2 Current NDC, Legacy NDC, 1 package rows 20241030_dabd3b95-01d3-014c-e053-2a95a90a0fec.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 Marketing end Sample Exclude flag Status 59958-601-01 59958060101 50 g in 1 BOTTLE (59958-601-01) 50 g 2022-03-21 0000-00-00 No No Current