Home NDC 78709-002-01 ALEX MD PHD Tinted Mineral Sunscreen
Product NDC 78709-002
Requested package NDC 78709-002-01
11-digit product format 787090002
Labeler code 78709
Product ID 78709-002_31682e51-745b-885d-e063-6394a90ae601
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler PHYSICIAN LABORATORIES INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-19
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 20.2; 6.8 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 ALEX MD PHD Tinted Mineral Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20.2 g/100g TITANIUM DIOXIDE 6.8 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 78709-002-01 ALEX MD PHD Tinted Mineral Sunscreen 1 in 1 CARTON CREAM 1 1 78709-002-01 ALEX MD PHD Tinted Mineral Sunscreen 65 g in 1 TUBE CREAM 65 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78709-002 ALEX MD PHD TINTED MINERAL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [PHYSICIAN LABORATORIES INC] 1 Current NDC, 2 package rows 20250330_93873c34-5c72-43c8-b6c2-c65b596191d7.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 78709-002-01 78709000201 1 TUBE in 1 CARTON (78709-002-01) / 65 g in 1 TUBE 1 tube 2025-03-19 No No Current