Home NDC 84444-506 GUIDANCE TO GLOW TRU SPF 35
Product NDC 84444-506
11-digit product format 844440506
Labeler code 84444
Product ID 84444-506_1bb558bf-848a-1991-e063-6394a90a03d8
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler GUIDANCE TO GLOW SKIN CARE
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-12
Substance ZINC OXIDE
Active strength 120 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 GUIDANCE TO GLOW TRU SPF 35
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 120 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84444-506-00 GUIDANCE TO GLOW TRU SPF 35 50 mL in 1 TUBE CREAM 50 1 84444-506-00 GUIDANCE TO GLOW TRU SPF 35 1 in 1 BOX CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84444-506 GUIDANCE TO GLOW TRU SPF 35 (ZINC OXIDE) CREAM [GUIDANCE TO GLOW SKIN CARE] 1 Current NDC, 2 package rows 20240627_21b4747b-b173-43c9-b0d4-1dbba5775ff8.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 84444-506-00 84444050600 1 TUBE in 1 BOX (84444-506-00) / 50 mL in 1 TUBE 1 tube 2024-06-12 No No Current