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 40 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f45f7953-c103-4900-e053-2a95a90ae399	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c888ce-3a3f-972b-e053-2a95a90a4fe3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKNI TINT	PML NYC, LLC	f4c44eb6-0a3d-2848-e053-2a95a90a58f3	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8925c-ac54-43b1-e053-2995a90a916c	2026-04-18	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c8b011-5e1d-378c-e053-2a95a90a09cf	2026-04-18	Warnings	Exact identifier application number: M020
EltaMD UV Daily SPF40	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	d967b7d0-453a-4420-886a-70ecf46528d2	2026-04-17	Warnings	Exact identifier application number: M020
ELROEL Pang Pang Sun Cushion S7	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	256bf56f-aefa-47ce-890c-5a3896c11b92	2026-04-17	Warnings	Exact identifier application number: M020
HOLIKA HOLIKA ALOE CICA UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE	Enprani Co., Ltd.	4fa30449-5332-1492-e063-6394a90a585f	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	3a43c7c0-7468-4b7a-95b9-f03e37f1b49b	2026-04-17	Warnings	Exact identifier application number: M020
FORGESKIN	MINERAL TALLOW SUNSCREEN	GUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD	4fa7e67d-cfc5-9f73-e063-6394a90ada50	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	a251eb20-02e6-4b55-b969-c1bef2f9d732	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Pink	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6684d69a-89ff-41e8-81f0-3e2367811a18	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	bf24d081-85f7-4a26-9416-ecff1fe59dec	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	4a09a01a-404f-4b67-91e0-666153f550e8	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion N-Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	cf7c4445-0382-47ab-aba9-b40d63e4f1cc	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	0e18d601-700a-4c1c-a434-22582253bd95	2026-04-17	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ddb3aa5e-cd1a-4792-b1b1-3604b368e010	2026-04-17	Warnings	Exact identifier application number: M020
House of Colour Tinted Sunscreen SPF 50	ZINC OXIDE	House of Colour, Inc.	763f5534-cda1-43f2-8a37-1eaa6a43c2e8	2026-04-17	Warnings	Exact identifier application number: M020
Sugargirl SPF 30 Sunscreen Illuminating Stick Sunlight	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	28c9f019-34fe-4568-ba35-38eb3c4cb19e	2026-04-17	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
58892-101-05	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