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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59958-200		I	Inactivated by FDA		2026-10-23
excluded package	package	59958-200	59958-200-01	I	Inactivated by FDA		2026-10-23

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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59958-200-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59958-200-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59958-200-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59958-200-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59958-200-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59958-200-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59958-200-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59958-200-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59958-200-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59958-200-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59958-200-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59958-200-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59958-200-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59958-200-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59958-200-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59958-200-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59958-200-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59958-200-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59958-200-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59958-200-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59958-200-02	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59958-200-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59958-200-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59958-200-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59958-200-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59958-200-01	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59958-200-02	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59958-200-03	I	Inactivated by FDA	`110d247fa046…`	`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
Ingredient	Strength
TITANIUM DIOXIDE	10.2 g/100g
ZINC OXIDE	3.7 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
59958-200-01	2025-01-30	956f9ecf-c0cc-621f-e053-dbdaa90a74ad	Owen Biosciences Drug Facts Anhydrous SPF 30
59958-200-01	2022-04-22	956f9ecf-c0cc-621f-e053-dbdaa90a74ad	Owen Biosciences Drug Facts Anhydrous SPF 30
59958-200-02	2022-04-22	960f7f55-d3a6-8e05-e053-dbdaa90a074a	Owen Biosciences Anhydrous SPF 30 30ml
59958-200-03	2022-04-22	97449f38-befd-f6ea-e053-dbdaa90aa703	Anhydrous SPF 30 30g Tube 59958-200-03
59958-200-03	2019-11-13	97449f38-befd-f6ea-e053-dbdaa90aa703	Anhydrous SPF 30 30g Tube 59958-200-03
59958-200-02	2019-10-29	960f7f55-d3a6-8e05-e053-dbdaa90a074a	Owen Biosciences Anhydrous SPF 30 30ml
59958-200-01	2019-10-21	956f9ecf-c0cc-621f-e053-dbdaa90a74ad	Owen Biosciences Drug Facts Anhydrous SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59958-200-02	Anhydrous SPF 30	30 g in 1 TUBE	CREAM	30	4
59958-200-03	Anhydrous SPF 30	30 g in 1 TUBE	CREAM	30	3
59958-200-01	Anhydrous SPF 30	100000 g in 1 DRUM	CREAM	100000	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Cyclomethicone	INACTIVE INGREDIENT	NMQ347994Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Cyclomethicone	INACTIVE INGREDIENT	NMQ347994Z	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE Black	INACTIVE INGREDIENT	XM0M87F357	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE Black	INACTIVE INGREDIENT	XM0M87F357	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Tribehenin	INACTIVE INGREDIENT	8OC9U7TQZ0	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1
Tribehenin	INACTIVE INGREDIENT	8OC9U7TQZ0	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59958-200	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241105_0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68.zip
59958-200	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250112_1510cae2-9c8f-45ba-b088-67747af3d30c.zip
59958-200	ANHYDROUS SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20220423_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 89 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228fab45-e0d2-f219-e063-6294a90a1ef6	2026-01-05	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228055ec-ff59-4412-e063-6394a90abe14	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	236bdb53-d7a5-43a2-8a0c-bce4a5522e26	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	4bd99626-690b-49e8-8c42-a2e2dbca09bf	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEIL	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f04ece6c-66b6-48e9-8f6b-e898a538ba00	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	05ffb157-5e28-4e94-866d-9e3371480d84	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CONCEALER N 1	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	eedf8065-8897-4773-9cbb-bab57d2dd04f	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEIL	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	beefe840-6f32-483b-8a37-2696adb8eea1	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	addd9885-362c-4ce0-9a6e-759e71d8756c	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	65ca1240-6ee8-40c0-b62f-3597e0872c6e	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CORRECTING VEIL n M	ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	15a258a0-61c3-4419-bcdb-a8197d5ae46f	2026-01-05	Warnings	Exact identifier application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	098c0a9b-2b96-6be3-e063-6294a90a959a	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Butter Screen SPF 30 Sunscreen Butter	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ae838725-79ab-4c17-905b-d4138ad6af1f	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	b98a9cec-3c48-4614-b091-4e59fa7d196e	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	5a9f8888-529d-40d7-9489-baa5ff657cb4	2026-01-05	Warnings	Exact identifier application number: M020
Yon-Ka 50 Mineral Fluid	ZINC OXIDE	Laboratoire MULTALER Yon-Ka	47a8c8b2-30ff-0d40-e063-6294a90ac461	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E	OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	6d2f82d5-b3af-44af-b6b0-de96a4cd95fc	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SPORTS BB LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	260a3eab-8fe6-4259-8dcc-3706ca1f6881	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE	SHISEIDO AMERICAS CORPORATION	4a16dbb7-e860-4aae-8e8b-67abbe8295bd	2026-01-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59958-200-01	59958020001	100000 g in 1 DRUM (59958-200-01)	100000 g	2021-01-01	0000-00-00	No	No	Current
59958-200-02	59958020002	30 g in 1 TUBE (59958-200-02)	30 g	2015-01-01	0000-00-00	No	No	Current
59958-200-03	59958020003	30 g in 1 TUBE (59958-200-03)	30 g	2011-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Owen Biosciences Anhydrous SPF 30 30ml	Owen Biosciences, Inc.	2026-01-08	HUMAN OTC DRUG LABEL	4
Owen Biosciences Drug Facts Anhydrous SPF 30	Owen Biosciences, Inc.	2022-04-22	HUMAN OTC DRUG LABEL	2
Anhydrous SPF 30 30g Tube 59958-200-03	Owen Biosciences, Inc.	2021-07-15	HUMAN OTC DRUG LABEL	3