Home NDC 85306-204 Tinted Mineral Sunscreen 20% Zinc Oxide
Product NDC 85306-204
11-digit product format 853060204
Labeler code 85306
Product ID 85306-204_458745f8-4e41-ae5d-e063-6394a90ab59f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler INTEGRATIVE AESTHETICS BOSTON, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-12
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 Tinted Mineral Sunscreen 20% Zinc Oxide
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 85306-204-60 Tinted Mineral Sunscreen 20% Zinc Oxide 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 85306-204 TINTED MINERAL SUNSCREEN 20% ZINC OXIDE (ZINC OXIDE) CREAM [INTEGRATIVE AESTHETICS BOSTON, LLC] 1 Current NDC, 1 package rows 20250328_31416d04-2d6f-7cf9-e063-6294a90a9806.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 85306-204-21 85306020421 60 g in 1 BOTTLE, PUMP (85306-204-21) 60 g 2024-06-04 No No Current 85306-204-60 85306020460 60 g in 1 BOTTLE, PUMP (85306-204-60) 60 g 2023-12-12 No No Current