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 188 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunglaze Body Gel Cream Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	3e6658a1-ae6a-9d19-e063-6294a90acae7	2025-09-09	Warnings	Exact identifier application number: M020
CLARINS Extra Firming Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	57f07e8a-1043-47e4-9d7b-6e78fdc34119	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	1d3218e6-8687-4a94-8bf7-3a867920cd1c	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	6c578ef8-5648-4428-b9a2-0952f9625253	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Kenvue Brands LLC	16ac7877-8dfd-3d69-e063-6394a90a5a8a	2025-09-08	Warnings	Exact identifier application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	388fb3db-29d2-bb29-e063-6394a90a4efb	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	d279693f-2254-4f3c-a121-144f95f9f25d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7f007540-8271-4d85-9d1e-b2b273ca05f8	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	5198d3df-ffa8-45eb-93d1-11e9f3961b92	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a82d85c4-c6ef-4083-b67a-2d6b0e8fc10d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	4ee6cac6-f649-436c-ada2-e024b86add69	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	edd4e8c3-b47a-4cfe-bf20-e856edb76e21	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	457f0a5c-c543-44f8-82d6-1096a8aab984	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	1452ffc4-a83f-472f-ae70-9e1002f88945	2025-09-08	Warnings	Exact identifier application number: M020
Protect and Hydrate Radiance Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	3e4db4f8-cba5-dbfd-e063-6394a90ab0a0	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e518d8a-f52b-4ae1-e063-6394a90aaa1e	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3c5a624a-8844-b782-e063-6294a90a478c	2025-09-08	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dbb07e2-971c-284d-e063-6294a90a437f	2025-09-06	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6	ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3e069cb2-c4c5-abf5-e063-6394a90a56b0	2025-09-06	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