Home NDC 85291-208 MATTE SHIELD SPF
Product NDC 85291-208
11-digit product format 852910208
Labeler code 85291
Product ID 85291-208_45739be6-b316-a23b-e063-6294a90a4773
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ACNE SOLUTIONS NYC INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-09
Substance ZINC OXIDE
Active strength 160 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 MATTE SHIELD SPF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 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 85291-208-15 MATTE SHIELD SPF 1.5 g in 1 PACKET CREAM 1.5 2 85291-208-50 MATTE SHIELD SPF 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85291-208 MATTE SHIELD SPF (ZINC OXIDE) CREAM [ACNE SOLUTIONS NYC INC] 1 Current NDC, 1 package rows 20250309_2faee7ef-fc0c-6d01-e063-6294a90a6d68.zip 85291-208 MATTE SHIELD SPF (ZINC OXIDE) CREAM [ACNE SOLUTIONS NYC INC] 1 Current NDC, 1 package rows 20250309_2fb00db0-4c37-56c6-e063-6294a90a8aff.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 45 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 85291-208-15 85291020815 1.5 g in 1 PACKET (85291-208-15) 1.5 g 2024-08-09 Yes No Current 85291-208-50 85291020850 50 g in 1 BOTTLE, PUMP (85291-208-50) 50 g 2024-08-09 No No Current