ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50

Product NDC
42851-052
11-digit product format
428510052
Labeler code
42851
Product ID
42851-052_b6d7357e-fb39-49c7-a081-23793e7298ce
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE
Active strength
0 g/g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42851-052DDiscontinued by firm2026-10-05
excluded packagepackage42851-05242851-052-12DDiscontinued by firm2026-10-05

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 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42851-052-12DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42851-052-12DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42851-052-12DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42851-052-12DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42851-052-12DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42851-052-12DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42851-052-12DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42851-052-12DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42851-052-12DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42851-052-12DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42851-052-12DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42851-052-12DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42851-052-12IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42851-052-12IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42851-052-12IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42851-052-12IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42851-052-12IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42851-052-12IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42851-052-12EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-052-60ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening60 g in 1 TUBELOTION60 g0.08 g in 1g1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN0ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
C13-14 IsoparaffinINACTIVE INGREDIENTE4F12ROE70ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438UZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Diisopropyl SebacateINACTIVE INGREDIENTJ8T3X564IHZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
ErythritolINACTIVE INGREDIENTRA96B954X6ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Homarine HydrochlorideINACTIVE INGREDIENT8866LNG61NZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Hydrogenated Palm GlyceridesINACTIVE INGREDIENTYCZ8EM144QZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Isodecyl NeopentanoateINACTIVE INGREDIENTW60VYE24XCZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Laureth-7INACTIVE INGREDIENTZ95S6G8201ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Lauryl LactateINACTIVE INGREDIENTG5SU0BFK7OZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Pentylene GlycolINACTIVE INGREDIENT50C1307PZGZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Phenyl TrimethiconeINACTIVE INGREDIENTDR0K5NOJ4RZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
PhytosphingosineINACTIVE INGREDIENTGIN46U9Q2QZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUYZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Sodium Dihydroxycetyl PhosphateINACTIVE INGREDIENTYWI33EV595ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
SoybeanINACTIVE INGREDIENTL7HT8F1ZODZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-052ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]1Legacy NDC20160714_73246324-eede-4933-9921-bb2b59642964.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42851-052-604285100526060 g in 1 TUBE60 gHistorical