TiZO Photoceutical AM Replenish - Tinted

Product NDC: 58892-101
11-digit product format: 588920101
Labeler code: 58892
Product ID: 58892-101_26bde5bd-1ffa-91f1-e063-6294a90adaf6
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: 2015-10-13
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 - 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
fbafa468-fce0-4597-bcb0-a816dc71ec7c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-101-50	TiZO Photoceutical AM Replenish - Tinted	1 in 1 CARTON	CREAM	1	3
58892-101-50	TiZO Photoceutical AM Replenish - Tinted	50 g in 1 TUBE	CREAM	50	3
58892-101-05	TiZO Photoceutical AM Replenish - Tinted	5 g in 1 TUBE	CREAM	5	1
58892-101-15	TiZO Photoceutical AM Replenish - Tinted	1.5 g in 1 PACKET	CREAM	1.5	1
58892-101-30	TIZO PHOTOCEUTICAL AM REPLENISH - TINTED	30 g in 1 TUBE	CREAM	30	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-101	TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20241115_fbafa468-fce0-4597-bcb0-a816dc71ec7c.zip
58892-101	TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2cc73c4f-30ea-0a51-e063-6394a90ac9a4.zip
58892-101	TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2cc84aba-006b-a78e-e063-6294a90ae040.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 148 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334ec844-5560-50f7-e063-6394a90a01be	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334f90d6-68e5-db37-e063-6294a90a5fb1	2025-12-08		Exact identifier application number: M020
Skin Apeel Pure Protect SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	18e78c7f-1523-a4f4-e063-6394a90aed97	2025-12-08	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c44baf4-9555-faad-e063-6294a90ab24f	2025-12-08	Warnings	Exact identifier application number: M020
Glow Stick	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c54b857-c017-a953-e063-6394a90a38df	2025-12-08	Warnings	Exact identifier application number: M020
Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c545e55-3f55-842b-e063-6394a90ae48e	2025-12-08	Warnings	Exact identifier application number: M020
Bare Barrier Sport	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c580794-eda3-de57-e063-6294a90a0303	2025-12-08	Warnings	Exact identifier application number: M020
Flawless Brightening Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Flawless Skin Care LLC	312e9ca0-a388-a546-e063-6294a90a15d6	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, protect	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2f8859cf-8277-6ea9-e063-6294a90a1a75	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2fb19ed7-8cee-ce80-e063-6394a90ad3dc	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2fb14c4f-a435-aa6e-e063-6394a90a7d8d	2025-12-08	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 40 Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Restoration Aesthetics	2fc4f701-eea2-7913-e063-6294a90a8693	2025-12-08	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 40 Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Skin Restoration Aesthetics	2fc55e8c-41d6-15cc-e063-6394a90ac543	2025-12-08	Warnings	Exact identifier application number: M020
Zinc Oxide SPF 40 Tinted	ZINC OXIDE	Skin Restoration Aesthetics	2fc60a39-789b-3d11-e063-6294a90a9abf	2025-12-08	Warnings	Exact identifier application number: M020
Zinc Oxide SPF 40 Non-Tinted	ZINC OXIDE	Skin Restoration Aesthetics	2fc68041-acfe-8db6-e063-6294a90ad8ba	2025-12-08	Warnings	Exact identifier application number: M020
Daily Tinted Mineral SPF	TITANIUM DIOXIDE, ZINC OXIDE	Skin Restoration Aesthetics	2fc6e168-b2c1-bf9d-e063-6394a90aade7	2025-12-08	Warnings	Exact identifier application number: M020
Ultra Solar Shield non-tinted moisturizing mineral SPF 40	ZINC OXIDE	Joyce Kelly Enterprises	365bdf7a-c034-beef-e063-6394a90a4dd7	2025-12-08		Exact identifier application number: M020
UV Shade tinted matte mineral SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Joyce Kelly Enterprises	365b3a1e-8410-da06-e063-6294a90a462f	2025-12-08		Exact identifier application number: M020
Solar Shield non-tinted matte mineral SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Joyce Kelly Enterprises	365b68a0-0f89-0f43-e063-6294a90a5eee	2025-12-08		Exact identifier application number: M020
Ultra UV Shade tinted moisturizing mineral SPF 40	ZINC OXIDE	Joyce Kelly Enterprises	365ba78a-b7df-a31f-e063-6394a90a1673	2025-12-08		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
58892-101-05	58892010105	5 g in 1 TUBE (58892-101-05)	5 g	2019-07-23		Yes	No	Current
58892-101-15	58892010115	1.5 g in 1 PACKET (58892-101-15)	1.5 g	2019-07-23		Yes	No	Current
58892-101-30	58892010130	30 g in 1 TUBE (58892-101-30)	30 g	2015-10-13		No	No	Current
58892-101-50	58892010150	1 TUBE in 1 CARTON (58892-101-50) / 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	2026-04-02	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	2025-01-28	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	2025-01-28	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-11-12	HUMAN OTC DRUG LABEL	3