Home NDC 85357-204 Sun Therapy Sunscreen
Product NDC 85357-204
11-digit product format 853570204
Labeler code 85357
Product ID 85357-204_46002963-21ee-887d-e063-6394a90a3a9a
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Skin Therapy Studio LLC�
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-13
Substance ZINC OXIDE
Active strength 200 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Sun Therapy Sunscreen
Listing expiration 2027-12-31 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 85357-204-15 Sun Therapy Sunscreen 1.5 g in 1 PACKET CREAM 1.5 2 85357-204-60 Sun Therapy Sunscreen 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 85357-204 SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ] 1 Current NDC, 1 package rows 20250521_357efafb-aa1c-0d69-e063-6394a90a5135.zip 85357-204 SUN THERAPY SUNSCREEN (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ] 1 Current NDC, 1 package rows 20250519_3544916b-3f63-3a7a-e063-6394a90ae507.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 302 of 346 · 6,912 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85357-204-15 85357020415 1.5 g in 1 PACKET (85357-204-15) 1.5 g 2024-03-13 Yes No Current 85357-204-60 85357020460 60 g in 1 BOTTLE, PUMP (85357-204-60) 60 g 2024-03-13 No No Current