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 87 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	1208d0f8-bb12-4574-b70e-3a76b11a64c7	2026-01-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KDC/One Development Corporation, Inc.	259f3fe3-2967-6c05-e063-6394a90a9e45	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	4084dd98-357f-4011-b0d4-db6536d2931f	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	9b4acc5e-fdaf-4fcb-83a9-69e430dd43de	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Sensitive Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	b42261c5-fa6e-4bb3-93c0-97032ab9f716	2026-01-07	Warnings	Exact identifier application number: M020
CabanaMilk Mineral Barrier Fluid SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	47d0fe4d-ad21-1004-e063-6394a90a9c19	2026-01-07	Warnings	Exact identifier application number: M020
CENTELLA RELIEF SOOTHING SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	IUNIK Co., Ltd.	47d170e3-dd76-d413-e063-6294a90ae8e4	2026-01-07	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum	ZINC OXIDE	SEORIN COMPANY Co., Ltd.	1e7cc417-3c57-c87c-e063-6394a90a670b	2026-01-07	Warnings	Exact identifier application number: M020
Proactiv Clear Skin SPF 30	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Alchemee, LLC	b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1	2026-01-07	Warnings	Exact identifier application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Oak Essentials, LLC	47d37f44-10b2-214f-e063-6294a90a5abc	2026-01-07	Warnings	Exact identifier application number: M020
PLUMSCREEN SPF 31	ZINC OXIDE	Le Prunier Farms, Inc.	e20eb996-2b64-6bd0-e053-2a95a90a4f92	2026-01-07	Warnings	Exact identifier application number: M020
BETA-GLUCAN MILD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	IUNIK Co., Ltd	47d6ad8b-1081-ee21-e063-6294a90a0e63	2026-01-07	Warnings	Exact identifier application number: M020
Koobarra Mineral Face Sunscreen SPF 50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	37cf8143-99f2-cca5-e063-6394a90a19a8	2026-01-07	Warnings	Exact identifier application number: M020
Solar Swipe Mineral Sunscreen SPF50	SOLAR SWIPE MINERAL SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	47d75d61-5295-3eab-e063-6394a90a01c1	2026-01-07	Warnings	Exact identifier application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN	ZINC OXIDE	JANE STREET LLC	dbdd3e6a-f09d-90cf-e053-2a95a90a98a0	2026-01-07	Warnings	Exact identifier application number: M020
RENEWALUXE SPF 50 Sunscreen	RENEWALUXE SPF 50 SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	1bc29960-5e73-e8ab-e063-6294a90a3f80	2026-01-06	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN	SPF50	Wild Child Laboratories PTY Ltd	2767ba3e-7434-d474-e063-6294a90aa4ff	2026-01-06	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit	SPF 50	Grace And Fire USA Inc.	47b7da8a-ea89-1402-e063-6294a90a23f9	2026-01-06	Warnings	Exact identifier application number: M020
Hawaiian Blend Essential Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	5a6e622f-2c00-406a-8860-d7081656f597	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	66c22f17-5418-42ff-97b2-33fa10f5eac3	2026-01-06	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