Anhydrous SPF 30

Product NDC
59958-200
11-digit product format
599580200
Labeler code
59958
Product ID
59958-200_47e3761d-a093-fcff-e063-6294a90af25b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
10.2; 3.7 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59958-200IInactivated by FDA2026-10-16
excluded packagepackage59958-20059958-200-01IInactivated by FDA2026-10-16

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 · 56 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59958-200-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59958-200-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59958-200-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59958-200-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59958-200-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59958-200-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59958-200-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59958-200-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59958-200-03UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59958-200-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59958-200-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59958-200-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59958-200-03IInactivated 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 productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59958-200-01IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59958-200-02IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59958-200-03IInactivated 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 productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59958-200-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59958-200-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59958-200-03IInactivated 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 productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59958-200-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59958-200-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59958-200-03IInactivated 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 productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59958-200-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59958-200-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59958-200-03IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59958-200-01IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59958-200-02IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage59958-200-03IInactivated by FDA110d247fa046…a55b01930146…

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
Anhydrous SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE10.2 g/100g
ZINC OXIDE3.7 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-200-02Anhydrous SPF 3030 g in 1 TUBECREAM304
59958-200-03Anhydrous SPF 3030 g in 1 TUBECREAM303
59958-200-01Anhydrous SPF 30100000 g in 1 DRUMCREAM1000002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE BlackINACTIVE INGREDIENTXM0M87F357ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE BlackINACTIVE INGREDIENTXM0M87F357ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]3Current NDC, Legacy NDC, 1 package rows20241105_0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68.zip
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_1510cae2-9c8f-45ba-b088-67747af3d30c.zip
59958-200ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]2Current NDC, Legacy NDC, 1 package rows20220423_6f56e04f-6d90-41e4-976e-e2e98dfbc98c.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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF CoconutAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.56078491-f7d6-97f7-e063-6394a90a6deb2026-07-07WarningsExact identifier
application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxideZINC OXIDESurprise Enterprise LLC38cf4325-9720-f511-e063-6394a90ad6282026-07-07WarningsExact identifier
application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC560c0f35-2132-52a6-e063-6394a90a2d242026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIEDelicate Cosmetics Inc560d1d19-87a6-179b-e063-6294a90ada5e2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYDelicate Cosmetics Inc560df34a-e6da-0792-e063-6394a90a7e712026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOUDelicate Cosmetics Inc560e37ae-87c0-39d2-e063-6394a90a2af42026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTEDelicate Cosmetics Inc560e4198-b07c-3d48-e063-6394a90a7be32026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXDelicate Cosmetics Inc560e47d5-c881-438c-e063-6394a90a30912026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLEDelicate Cosmetics Inc560e5de5-1350-4046-e063-6394a90abffa2026-07-07WarningsExact identifier
application number: M020
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLEDelicate Cosmetics Inc560e5558-8e46-7736-e063-6294a90acb052026-07-07WarningsExact identifier
application number: M020
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Products1d4be26a-4695-491c-85d1-86824e1cd0292026-07-06WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLC71856cb3-9386-4569-80e4-92826342e3862026-07-06WarningsExact identifier
application number: M020
Stay Ageless SunscreenBROAD SPECTRUM SPF 30TOXFAIRY, LLC55f7e07e-1689-6d38-e063-6294a90a91192026-07-06WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
application number: M020
RR SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Inc87244432-2967-4145-89cd-11a7567083a32026-07-06WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.35af90d3-dfe1-30dc-e063-6294a90a10a52026-07-05WarningsExact identifier
application number: M020
MDP PEPTIDE 9 BIO SUN PROHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANESKINIDEA CO., LTD26db53cd-dd82-8790-e063-6394a90a92b12026-07-03WarningsExact identifier
application number: M020
SPF 50 plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDETheravita LLCd8e276cc-0292-499d-9075-a83a2d3fafcc2026-07-02WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.5880b275-91fc-4589-a076-0e55409425d82026-07-02Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-200-0159958020001100000 g in 1 DRUM (59958-200-01) 100000 g2021-01-010000-00-00NoNoCurrent
59958-200-025995802000230 g in 1 TUBE (59958-200-02) 30 g2015-01-010000-00-00NoNoCurrent
59958-200-035995802000330 g in 1 TUBE (59958-200-03) 30 g2011-03-010000-00-00NoNoCurrent