FDA.reportPublic FDA data

Chem Free SPF 30

Product NDC
59958-404
11-digit product format
599580404
Labeler code
59958
Product ID
59958-404_2b996b63-5943-0663-e063-6394a90a35f2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-19
Substance
ZINC OXIDE
Active strength
21 g/100g
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct59958-404UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59958-40459958-404-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Chem Free SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE21 g/100g

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
7e5930fe-eb0f-4a21-8065-8831dd5b351cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-404-012021-07-15C16284748780-1ba0f9c33-46b3-a910-e053-dadaa90a0b85-403 Chem Free SPF 30
59958-404-012021-01-29C16284748780-1ba0f9c33-46b3-a910-e053-dadaa90a0b85-403 Chem Free SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-404-01Chem Free SPF 3050 g in 1 TUBECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-404CHEM FREE SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]5Current NDC, Legacy NDC, 1 package rows20250114_7e5930fe-eb0f-4a21-8065-8831dd5b351c.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 21 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c09714-6137-7102-e063-6294a90a72a42026-06-08WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c13cc3-208e-ae7d-e063-6294a90a2a032026-06-08WarningsExact identifier
application number: M020
Innisfree Daily UV Defense Mineral SunscreenZINC OXIDE LOTIONInnisfree Corporation0e9cd3e5-cff8-7594-e063-6394a90aad902026-06-08WarningsExact identifier
application number: M020
Paulas Choice Lipscreen Broad Spectrum SPF 50OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENECosmetic Solutions LLC4c37e10c-3da5-4a48-b2c1-1b99ce9a02c12026-06-08WarningsExact identifier
application number: M020
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
application number: M020
Inflair Elevate SPF15 MoisturizerETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Yapheon Health Industry Co., Ltd53a724e9-229e-eea4-e063-6294a90a7d5e2026-06-07WarningsExact identifier
application number: M020
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
application number: M020
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC538429b8-4f0e-e825-e063-6294a90a59052026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC5384da3c-4017-a3c1-e063-6294a90ae9a32026-06-05WarningsExact identifier
application number: M020
MEDULTIMA ADVENTURE SUNSCREENHOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.5368b2b3-fd80-9659-e063-6394a90a0ad32026-06-04WarningsExact identifier
application number: M020
WEN SixThirteen SPF 20 Dry Oil Intensive TreatmentOCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONEWEN by Chaz Dean536e6291-f5ca-37a4-e063-6394a90adfdb2026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
application number: M020
Glow Gloss Lip Balm SPF 40 Vanilla Soft ServeHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATESupergoop!26d2897f-46a7-52b2-e063-6394a90aed322026-06-04WarningsExact identifier
application number: M020
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
application number: M020
Abib No White Cast SPF Gift SetHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.537420bb-9fd8-0649-e063-6394a90aa8cf2026-06-04WarningsExact identifier
application number: M020
Airy sunstick smooting barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.f8203d54-cd3d-314d-e053-6394a90ac10d2026-06-04WarningsExact identifier
application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-404-015995804040150 g in 1 TUBE (59958-404-01) 50 g2017-07-190000-00-00NoNoCurrent