Home NDC 85363-204 Prime And Protect Dewy
Product NDC 85363-204
11-digit product format 853630204
Labeler code 85363
Product ID 85363-204_4603d0f3-a854-95bc-e063-6394a90a9a7f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Kalon Skin Studio, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-25
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 Prime And Protect Dewy
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 85363-204-60 Prime And Protect Dewy 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 85363-204 PRIME AND PROTECT DEWY (ZINC OXIDE) CREAM [KALON SKIN STUDIO, LLC] 1 Current NDC, 1 package rows 20250522_3593cefe-a08f-eb88-e063-6394a90aaff6.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 85363-204-60 85363020460 60 g in 1 BOTTLE, PUMP (85363-204-60) 60 g 2023-07-25 No No Current