Home NDC 85753-101 Mist Me SPF-40
Product NDC 85753-101
11-digit product format 857530101
Labeler code 85753
Product ID 85753-101_cf09d70c-cebe-4c99-a2a5-a822e09d2500
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Cove Suncare LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-01
Substance ZINC OXIDE
Active strength 22 g/100mL
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 Mist Me SPF-40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 22 g/100mL
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 85753-101-01 Mist Me SPF-40 162 mL in 1 CAN AEROSOL, SPRAY 162 1
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 361 · 7,213 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85753-101-01 85753010101 162 mL in 1 CAN (85753-101-01) 162 ml 2025-11-01 No No Current