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 47 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4a822-a7ab-b374-e063-6394a90a8508	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef4d44e-3421-535f-e063-6294a90a2fea	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef5baf7-00b1-97aa-e063-6294a90aab9c	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef5dcd4-b2d0-bcd1-e063-6294a90a871f	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef669b9-df00-8965-e063-6394a90ab335	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Acupac Packaging, Inc.	4ef6a60a-6634-e79b-e063-6394a90a3daa	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef6b5fb-5495-001c-e063-6394a90ab7b3	2026-04-08	Warnings	Exact identifier application number: M020
Sunright Lip Balm	OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc.	dfdb2d0a-c646-4c44-b648-e2fdd604cdc9	2026-04-08	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light Golden	TITANIUM DIOXIDE	NSE Products, Inc.	faae6f47-19f3-41cb-8e0d-388569b5c73d	2026-04-07	Warnings	Exact identifier application number: M020
Ultra Sunscreen	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	Jiangsu Senwo Medical Technology Co., Ltd.	4ed974b8-6c11-08e0-e063-6294a90a7713	2026-04-07	Warnings	Exact identifier application number: M020
Vivaiodays SPF 30 Sunscreen with Turmeric	SPF 30 SUNSCREEN WITH TURMERIC	5SENCO INC	4ee0c93a-7f50-2bda-e063-6294a90abff4	2026-04-07	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc	4ee39bbf-b7d7-8f87-e063-6294a90a2539	2026-04-07	Warnings	Exact identifier application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREEN	ZINC OXIDE	Beverly Hills MD, LLC	4ed34743-cc68-501b-e063-6294a90ad396	2026-04-07	Warnings	Exact identifier application number: M020
Nu Colour Bioadaptive BB plus Foundation - Beige	TITANIUM DIOXIDE	NSE Products, Inc.	f74e83fe-41a0-4998-ae53-30ed5af47592	2026-04-07	Warnings	Exact identifier application number: M020
Thinksport SPF 30	ZINC OXIDE	thinkOperations,LLC	33065919-9b4e-4b2b-9306-a706558241c8	2026-04-07	Warnings	Exact identifier application number: M020
Nutricentials Day Dream Protective	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc	daca8347-f7e7-4733-bd22-1da7a6076fad	2026-04-06	Warnings	Exact identifier application number: M020
TONEfitSUN Ultra Moisturizing Vegan Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory	4ec58c23-16b1-03bb-e063-6394a90a46c0	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15	HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	be36b83f-662d-49c6-a12f-a64e11721d0c	2026-04-06	Warnings	Exact identifier application number: M020
Pure Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Liz Corporation Ltd	4eca5257-6840-2a33-e063-6394a90ade28	2026-04-06	Warnings	Exact identifier application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Parfums Christian Dior	4a5147f3-4e52-447a-a89c-058aea8a612c	2026-04-06	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