Home NDC 83286-010 PHYSICAL TINTED MOISTURIZER SPF44
Product NDC 83286-010
11-digit product format 832860010
Labeler code 83286
Product ID 83286-010_9b3c3980-473f-4cbb-92f0-cca9d5d29ed5
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Drmtlgy, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-08
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 10; 5.5 g/100g; g/100g
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 PHYSICAL TINTED MOISTURIZER SPF44
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10 g/100g TITANIUM DIOXIDE 5.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP 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 83286-010-01 PHYSICAL TINTED MOISTURIZER SPF44 58 g in 1 BOTTLE, PUMP CREAM 58 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83286-010 PHYSICAL TINTED MOISTURIZER SPF44 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [DRMTLGY, LLC] 1 Current NDC, 1 package rows 20250427_483d0d28-56f3-4b37-af03-0331e1653d73.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 83286-010-01 83286001001 58 g in 1 BOTTLE, PUMP (83286-010-01) 58 g 2025-04-08 No No Current