TiZO Photoceutical AM Replenish Non-Tinted

Product NDC: 58892-107
11-digit product format: 588920107
Labeler code: 58892
Product ID: 58892-107_26e7189b-149f-97c4-e063-6394a90a0294
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-05
Substance: ZINC OXIDE
Active strength: 160 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: TiZO Photoceutical AM Replenish Non-Tinted
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	160 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-107-50	TiZO Photoceutical AM Replenish Non-Tinted	50 g in 1 TUBE	CREAM	50	3
58892-107-50	TiZO Photoceutical AM Replenish Non-Tinted	1 in 1 CARTON	CREAM	1	3
58892-107-05	TiZO Photoceutical AM Replenish Non-Tinted	5 g in 1 TUBE	CREAM	5	1
58892-107-15	TiZO Photoceutical AM Replenish Non-Tinted	1.5 g in 1 PACKET	CREAM	1.5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20241121_c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6.zip
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250202_2cb77125-ff77-2060-e063-6294a90ab69f.zip
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2cc62961-dcef-d7db-e063-6394a90a9ebd.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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TALLOW SUNSCREEN	NON-NANO ZINC OXIDE	FOUNDATION COMMERCE INC	363e38bf-b4b4-dcc4-e063-6294a90a5d2f	2025-05-28	Warnings	Exact identifier application number: M020
CoreTex SunX 50 Facestick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	364989ea-c93b-d404-e063-6294a90abd09	2025-05-28	Warnings	Exact identifier application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30	OCTINOXATE, ZINC OXIDE	SOLVADERM LLC	86dbd8c3-e95a-49a8-afe6-ff9d985e28ba	2025-05-27	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350b4cce-1627-5b8f-e063-6294a90aa6bf	2025-05-26	Warnings	Exact identifier application number: M020
Protect Daily Ritual Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35ce8307-387b-2b40-e063-6294a90a28bc	2025-05-23		Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	ONESKIN INC.	35d57d3f-376c-2307-e063-6294a90adf51	2025-05-23	Warnings	Exact identifier application number: M020
Oathology Inzincable Lip Balm SPF 35	ZINC OXIDE	SKINOATH LLC	289a5492-af57-42e5-82af-3f1e4b369d68	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light	ZINC OXIDE	ALLI LLC	3cb4459b-1776-414a-b5c4-0ffb9f1df766	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark	ZINC OXIDE	ALLI LLC	81633684-f9ac-45cb-8a3e-f0c30b229a82	2025-05-22	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35bea4f3-c19e-3e2e-e063-6394a90aeb69	2025-05-22		Exact identifier application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	35c106b6-9a80-01e3-e063-6294a90abc35	2025-05-22	Warnings	Exact identifier application number: M020
COSRX	AIRY-LIGHT CLEAR SUNCREEN STICK	COSRX inc.	313b1a73-8863-c458-e063-6394a90a01d6	2025-05-20	Warnings	Exact identifier application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	MELAN INC.	f627b17f-d2dc-47bd-b865-08995995e861	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	63e078a3-d5df-4458-a745-e306d734e6be	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	90531e8f-15c6-49ac-96a4-3bdfab2bfd9b	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	28db9f44-780f-4cd5-940e-3ee779f38247	2025-05-20	Warnings	Exact identifier application number: M020
Mineral Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595149d-0735-6bea-e063-6394a90a618a	2025-05-20		Exact identifier application number: M020
Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595735e-c25f-eb48-e063-6294a90aac0f	2025-05-20		Exact identifier application number: M020
Coola Clear California Summers	OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE	COOLA, LLC	358009c4-492d-ac03-e063-6294a90af227	2025-05-19	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	ONESKIN INC.	3581f578-e19e-9ace-e063-6294a90acc34	2025-05-19	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
58892-107-05	58892010705	5 g in 1 TUBE (58892-107-05)	5 g	2019-07-23		Yes	No	Current
58892-107-15	58892010715	1.5 g in 1 PACKET (58892-107-15)	1.5 g	2019-07-23		Yes	No	Current
58892-107-50	58892010750	1 TUBE in 1 CARTON (58892-107-50) / 50 g in 1 TUBE	1 tube	2019-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zinc Oxide - Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-01-28	HUMAN OTC DRUG LABEL	1
Zinc Oxide - Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals, LTD \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-01-27	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-11-14	HUMAN OTC DRUG LABEL	3