Home NDC 42851-092 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50
Product NDC 42851-092
11-digit product format 428510092
Labeler code 42851
Product ID 42851-092_44883680-7c35-a55f-e063-6394a90aaa42
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene
Dosage form GEL
Route TOPICAL
Labeler ZO Skin Health, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-30
Substance OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength 4.5; 1.35; 2.25 g/45g; g/45g; g/45g
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42851-092-45 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42851-092-45 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42851-092-45 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42851-092-45 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42851-092-45 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42851-092-45 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42851-092-45 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42851-092-45 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42851-092-45 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42851-092-45 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42851-092-45 367a005e9d99…383a685ebd0f…
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 Gel Sunscreen Broad-Spectrum SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 4.5 g/45g AVOBENZONE 1.35 g/45g OCTISALATE 2.25 g/45g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup G63QQF2NOX Internal UNII lookup 4X49Y0596W 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 42851-092-34 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 1 in 1 CARTON GEL 1 4 42851-092-34 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 96 g in 1 TUBE GEL 96 4
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 109 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3aadc018-edbb-033b-e063-6394a90afbe7 2025-12-17 Warnings Exact identifier application number: M020 Non-Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3ab0298d-b2d0-591e-e063-6394a90a3177 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3cce3120-748e-a7fd-e063-6394a90a4d51 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3ccea6c0-8c27-6b26-e063-6294a90a0931 2025-12-17 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE JKH Aesthetics LLC 369c1d16-5980-e1dc-e063-6394a90a3104 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3d5a2662-02e3-3a95-e063-6294a90a8120 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3d5ab3f6-10b9-2a21-e063-6294a90a3428 2025-12-17 Warnings Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JKH Aesthetics LLC 369ccb8f-d9b6-1fd2-e063-6394a90ace20 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364cafdd-fe86-cb23-e063-6394a90afb09 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364d2231-3db3-0a59-e063-6394a90a6777 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TINTED TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad4442-e45f-90e2-e063-6294a90aeef5 2025-12-17 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42851-092-34 42851009234 1 TUBE in 1 CARTON (42851-092-34) / 96 g in 1 TUBE 1 tube 2025-10-30 No No Current