Home NDC 83531-497 KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men
Product NDC 83531-497
11-digit product format 835310497
Labeler code 83531
Product ID 83531-497_0976cb4f-2ac9-fc33-e063-6394a90a11c7
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler ACTIVE LIFE INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-19
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 60; 60 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 KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 60 mg/mL ZINC OXIDE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP 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 83531-497-00 KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men 118 mL in 1 BOTTLE CREAM 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83531-497 KOVR ALL-NATURAL SPF-30 MOISTURIZING SUNSCREEN FOR MEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ACTIVE LIFE INC] 2 Current NDC, 1 package rows 20231106_bf766aab-a52d-41e8-a06a-f2e536d2219b.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 83531-497-00 83531049700 118 mL in 1 BOTTLE (83531-497-00) 118 ml 2023-06-19 No No Current