ZO SKIN HEALTH

Product NDC: 42851-155
11-digit product format: 428510155
Labeler code: 42851
Product ID: 42851-155_f74e99ed-574f-46d5-bda5-c5cf16c674b5
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE and ZINC OXIDE
Dosage form: KIT
Labeler: ZO Skin Health, Inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-01-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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	42851-155		I	Inactivated by FDA		2026-10-05
excluded package	package	42851-155	42851-155-03	I	Inactivated by FDA		2026-10-05

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 · 44 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	42851-155-03	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	42851-155-03	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	42851-155-03	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	42851-155-03	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	42851-155-03	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	42851-155-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42851-155-03	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42851-155-03	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42851-155-03	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42851-155-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42851-155-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42851-155-03	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42851-155-03	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42851-155-03	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42851-155-03	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42851-155-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
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	42851-155-03	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 package	package	42851-155-03	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 package	package	42851-155-03	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 package	package	42851-155-03	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 package	package	42851-155-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42851-155-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42851-155-03	2020-01-31	C162847	48780-1	9d75b9d1-2253-f424-e053-dadaa90a57ce	ZO ® SKIN HEALTH OSSENTIAL ® DAILY POWER DEFENSE ANTI-AGING FORMULA + OCLIPSE ® SUNSCREEN + PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42851-051-03	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA and OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION	30 mL in 1 BOTTLE, PUMP	LOTION	30 mL	37 mg in 1mL	1
42851-155-03	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA and OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION	1 in 1 CARTON	KIT	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
CALCIUM BEHENATE	INACTIVE INGREDIENT	J5VFA9V6YG	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
CYCLOMETHICONE 4	INACTIVE INGREDIENT	CZ227117JE	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	INACTIVE INGREDIENT	9E4CO0W6C5	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
DIMETHICONOL (40 CST)	INACTIVE INGREDIENT	343C7U75XW	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
LAURETH-23	INACTIVE INGREDIENT	N72LMW566G	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
METHICONE (20 CST)	INACTIVE INGREDIENT	6777U11MKT	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER	INACTIVE INGREDIENT	EG97988M5Q	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
PEG-10 DIMETHICONE (600 CST)	INACTIVE INGREDIENT	8PR7V1SVM0	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
PPG-2 MYRISTYL ETHER PROPIONATE	INACTIVE INGREDIENT	88R97D8U8A	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	01S2G2C1E4	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1
TRIBEHENIN	INACTIVE INGREDIENT	8OC9U7TQZ0	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42851-155	ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]	1	Legacy NDC, 2 package rows	20140710_2d99bde7-2ecb-4609-80c4-739f08b9d1eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42851-051-03	42851005103	30 mL in 1 BOTTLE, PUMP	30 ml	Historical
42851-155-03	42851015503	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TITANIUM DIOXIDE and ZINC OXIDE	ZO Skin Health, Inc. \| Owen Biosciences \| PakLab, Inc.	2014-04-22	HUMAN OTC DRUG LABEL	1