Home NDC 42851-060 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30
Product NDC 42851-060
11-digit product format 428510060
Labeler code 42851
Product ID 42851-060_25a24c79-21ec-795b-e063-6294a90a7b97
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ZO Skin Health, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-31
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 10; 200 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 42851-060-15 excluded package package 42851-060-30 excluded package package 42851-060-75
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 Sunscreen Plus Primer Broad-Spectrum SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 10 mg/mL ZINC OXIDE 200 mg/mL
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 42851-060-15 2022-10-06 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75 42851-060-30 2022-10-06 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75 42851-060-75 2022-10-06 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75 42851-060-15 2022-07-29 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75 42851-060-30 2022-07-29 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75 42851-060-75 2022-07-29 ZO ® Skin Health Sunscreen + Primer Broad-Spectrum SPF 30 National Drug Codes: 42851-060-15, 42851-060-30, and 42851-060-75
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42851-060-15 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 1 in 1 CARTON CREAM 1 8 42851-060-15 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 15 mL in 1 BOTTLE, PUMP CREAM 15 8 42851-060-30 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 1 in 1 CARTON CREAM 1 8 42851-060-30 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 30 mL in 1 BOTTLE, PUMP CREAM 30 8 42851-060-75 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 1 in 1 CARTON CREAM 1 8 42851-060-75 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 75 mL in 1 BOTTLE, PUMP CREAM 75 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42851-060 ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ZO SKIN HEALTH, INC.] 8 Current NDC, Legacy NDC, 6 package rows 20241031_9a4f5be1-da04-48b9-897a-57f4a3d9d1ec.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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42851-060-15 42851006015 1 BOTTLE, PUMP in 1 CARTON (42851-060-15) / 15 mL in 1 BOTTLE, PUMP 2019-10-31 0000-00-00 No No Current 42851-060-30 42851006030 1 BOTTLE, PUMP in 1 CARTON (42851-060-30) / 30 mL in 1 BOTTLE, PUMP 2019-10-31 0000-00-00 No No Current 42851-060-75 42851006075 1 BOTTLE, PUMP in 1 CARTON (42851-060-75) / 75 mL in 1 BOTTLE, PUMP 2019-10-31 0000-00-00 No No Current