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		2026-10-21
excluded package	package	59958-200	59958-200-01	I	Inactivated by FDA		2026-10-21

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 · 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 71 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	ea630f2c-49a7-4900-a0ac-b0e1c554aff9	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	cc9c9b69-a0ea-44ac-a590-2cd241ce3162	2026-01-22	Warnings	Exact identifier application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442	HOMOSALATE,OCTISALATE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	e38a10a8-73ac-4fc5-bbde-537ccb845e6f	2026-01-22	Warnings	Exact identifier application number: M020
Designer Lip Smoothie SPF 15 Lip Balm	AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM	Australian Gold	6fd1bd4f-ef94-42b5-a26c-2a02718c113f	2026-01-22	Warnings	Exact identifier application number: M020
Australian Gold SPF 15 Lip Balm	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY	Australian Gold	92966c2d-b61a-4f8b-a5c1-8dfb6352c82f	2026-01-22	Warnings	Exact identifier application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	DONGDONGGURIMOO CO.,LTD.	4907eb9c-3978-27ed-e063-6394a90a9f66	2026-01-22	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	be9f7608-cfaa-4b16-83dd-0580047af56c	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6b27df44-c441-4ae8-a1b0-a9cf2fff6f21	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3c295f6b-6202-a2e1-e063-6394a90a9a60	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	b2eee48f-b644-403c-a57e-04a1491bc386	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ebcc2c6c-a039-48d5-8c1c-5b347254c4c2	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6967f8bc-3092-44a9-926a-6c11676425e5	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	37d4d8c1-e76b-48a3-9a13-f0543af1b28f	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	fa5046f2-a6db-4ac3-a78f-1b5df075d7e8	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	0c5fc63f-1899-4406-944a-1cdcdf8b4277	2026-01-21	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	58a84ecd-3f27-40fc-8e0b-e29192679e6b	2026-01-21	Warnings	Exact identifier application number: M020
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE AVON COMPANY	48e8b7f5-6977-bfae-e063-6394a90a888b	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	32725ca7-ec21-4643-bdc6-278fd647b95d	2026-01-21	Warnings	Exact identifier application number: M020
Australian Gold SPF 30 Lip Balm	AVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUM	Australian Gold	e6877f7a-3aaa-4096-bcb5-eae0aa2532e5	2026-01-21	Warnings	Exact identifier application number: M020
MINICELL UV SHIELD SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CELINA CO., LTD.	48eff8fa-deec-a434-e063-6294a90aa861	2026-01-21	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