Home NDC 85325-204 Signature Tint SPF 40
Product NDC 85325-204
11-digit product format 853250204
Labeler code 85325
Product ID 85325-204_45af108d-892d-0b66-e063-6394a90a52ef
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ADVANCED AESTHETICS SKIN CARE STUDIO, INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-12
Substance ZINC OXIDE
Active strength 200 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 Signature Tint SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 mg/g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85325-204-60 Signature Tint SPF 40 60 g in 1 BOTTLE, PUMP CREAM 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85325-204 SIGNATURE TINT SPF 40 (ZINC OXIDE) CREAM [ADVANCED AESTHETICS SKIN CARE STUDIO, INC] 1 Current NDC, 1 package rows 20250508_348f1bd3-1245-2d9a-e063-6394a90a4787.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 85325-204-60 85325020460 60 g in 1 BOTTLE, PUMP (85325-204-60) 60 g 2020-10-12 No No Current