Home NDC 42851-064 ZO Skin Health Broad-Spectrum Sunscreen SPF 50
Product NDC 42851-064
11-digit product format 428510064
Labeler code 42851
Product ID 42851-064_25a7063a-0d73-c596-e063-6394a90a01a3
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ZO Skin Health, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 7.552; 17.7 mg/118g; mg/118g
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 ZO Skin Health Broad-Spectrum Sunscreen SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 7.552 mg/118g ZINC OXIDE 17.7 mg/118g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42851-064-04 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 118 g in 1 TUBE CREAM 118 4 42851-064-04 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42851-064 ZO SKIN HEALTH BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ZO SKIN HEALTH, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241101_d817f80b-a998-b67e-e053-2995a90a1971.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 81 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42851-064-04 42851006404 1 TUBE in 1 CARTON (42851-064-04) / 118 g in 1 TUBE 1 tube 2022-08-15 0000-00-00 No No Current