Home NDC 85449-201 Complexion Correction Tinted Primer Sunscreen
Product NDC 85449-201
11-digit product format 854490201
Labeler code 85449
Product ID 85449-201_46008655-4288-6249-e063-6294a90a0e11
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-29
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 80; 38 mg/g; mg/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 Complexion Correction Tinted Primer Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85449-201-85 Complexion Correction Tinted Primer Sunscreen 85 g in 1 BOTTLE, PUMP CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85449-201 COMPLEXION CORRECTION TINTED PRIMER SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY] 1 Current NDC, 1 package rows 20250521_357e75ec-473e-df76-e063-6294a90a70c7.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 85449-201-85 85449020185 85 g in 1 BOTTLE, PUMP (85449-201-85) 85 g 2019-08-29 No No Current