FDA.reportPublic FDA data

Sunblocz

Product NDC
52358-0004
11-digit product format
523580004
Labeler code
52358
Product ID
52358-0004_259f1fe0-327b-a04f-e063-6394a90a534d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Olen Skin Care Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-21
Substance
ZINC OXIDE
Active strength
43.4 g/177mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52358-000452358-0004-1DDiscontinued by firm2026-10-21

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Sunblocz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE43.4 g/177mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36fec1f1-5e8b-5764-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52358-0004-1Sunblocz177 mL in 1 TUBECREAM1776
52358-0004-2Sunblocz118 mL in 1 TUBECREAM1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52358-0004SUNBLOCZ (ZINC OXIDE) CREAM [OLEN SKIN CARE CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241031_36fec1f1-5e8b-5764-e054-00144ff8d46c.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 58 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
application number: M020
JAYSUING White Birch Moisturizing Sunscreen CreamTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.4c174691-cc32-b2e4-e063-6294a90a0f732026-03-02WarningsExact identifier
application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association6307627a-94e2-47ea-8519-68975716dd6e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationa38e150e-2e50-4936-ae46-408f9cf82d152026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association87811c86-19d2-4179-8d22-2aeb4680ff572026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationd7215a32-00a9-4b70-8597-8ea91f546c1e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association9fccccd4-2d2e-4812-85b1-bbeb44ff04ea2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.be702a3b-1652-4468-803d-295100d3e3e22026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.644ec129-15c9-4ac1-8362-5b4c2e58ab9a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF BeautySPF BEAUTYWalmart Inc.f06f26af-81d6-4603-b377-fd12430ec9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF MoisturizerSPF MOISTURIZERWalmart Inc.41de3171-9ed3-45da-96fb-dfcf419122292026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Facial MoisturizerDAILY FACIAL MOISTURIZER SPF 15Walmart Inc.2cec9c90-2e64-f005-e063-6294a90a87532026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.309d881d-40e0-37bc-e063-6294a90a37692026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a2026-02-27WarningsExact identifier
application number: M020
MELAO Sunscreen StickETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd4ba15c03-0409-918b-e063-6294a90ac6ee2026-02-26WarningsExact identifier
application number: M020
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
application number: M020
Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4bbc0639-3a80-1c28-e063-6394a90a3c002026-02-26WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52358-0004-152358000401177 mL in 1 TUBE177 mlHistorical
52358-0004-252358000402118 mL in 1 TUBE (52358-0004-2) 118 ml2018-06-070000-00-00NoNoCurrent