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 127 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36af24e2-015a-a9a7-e063-6294a90a2fce	2025-12-15		Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BASS & KLASS, INC	36add3a3-f1ff-3986-e063-6394a90ab7fe	2025-12-15		Exact identifier application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted	ZINC OXIDE	True Beauty Brows & Skin Care	37dc70ba-a6bb-fe09-e063-6394a90a5129	2025-12-15		Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	bcbab676-fbe2-f0cc-e053-2a95a90ad4d2	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f14cf2b8-b110-1210-e053-2995a90a0102	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f1504311-4865-5499-e053-2995a90acdcd	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	f14d70f1-440b-900d-e053-2995a90a30a0	2025-12-15	Warnings	Exact identifier application number: M020
REVERSE Brightening Defense Fluid	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Rodan & Fields	dc230e1e-bfb8-4d7c-bad5-bff77d78220e	2025-12-15	Warnings	Exact identifier application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	bbf15e58-c160-d599-e053-2a95a90a0696	2025-12-14	Warnings	Exact identifier application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-Free	ZINC OXIDE	COOLA LLC	ee8706b0-ad42-403a-be7c-b660f040a244	2025-12-14	Warnings	Exact identifier application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREE	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	cfc21b1a-4a26-1573-e053-2995a90a2d50	2025-12-14	Warnings	Exact identifier application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kopari Beauty	7c96b799-e24d-473f-8f0a-3fad83d5ed48	2025-12-14	Warnings	Exact identifier application number: M020
WOODSLEEP Sunscreen Balm	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	45cfc7ed-34a6-1f45-e063-6394a90a902b	2025-12-13	Warnings	Exact identifier application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50	ZINC OXIDE 24%	UNIVERSKIN	45d242de-cbd8-e7ea-e063-6394a90aaebf	2025-12-13	Warnings	Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE SPF 50	ALAINA HEALTHCARE PRIVATE LIMITED	b7847d4f-2517-4b58-8e31-676c9d6e484d	2025-12-12	Warnings	Exact identifier application number: M020
Lip Protecting	TITANIUM DIOXIDE, ZINC OXIDE	JOHANNA'S SKIN CARE	3544b8f2-2651-4c01-e063-6394a90ae53d	2025-12-12		Exact identifier application number: M020
Tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	JOHANNA'S SKIN CARE	3544faa1-ebdf-5dbd-e063-6394a90a7631	2025-12-12		Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	SOLUTIONS SKIN CARE LLC	40323dfa-29e4-1464-e063-6294a90aa65c	2025-12-12	Warnings	Exact identifier application number: M020
Zinc 20Percent SPF 40	ZINC OXIDE	JOHANNA'S SKIN CARE	3545ed3e-b42f-d29d-e063-6394a90a8efe	2025-12-12		Exact identifier application number: M020
Replenishing Daily Protection Non-Tinted	ZINC OXIDE	SOLUTIONS SKIN CARE LLC	40332cf3-e4e5-0c00-e063-6394a90a683d	2025-12-12	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