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 173 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Land Shark SPF 8	OCTINOXATE AND OXYBENZONE	Tropical Seas, Inc.	b5e68448-4131-1c6c-e053-2a95a90a014a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 40	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d204c38c-b5d1-3511-e053-2a95a90a9dc8	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e4e63c-3e51-0a78-e053-2a95a90abd87	2025-11-04	Warnings	Exact identifier application number: M020
Reef Babies SPF 50 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	8cd68b09-2578-4519-b00e-e83e0e440815	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e44be7-3a46-34e2-e053-2a95a90a9660	2025-11-04	Warnings	Exact identifier application number: M020
Reef Kids SPF 30 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	005a9e7c-e392-4b9a-911f-d7586f7ae94e	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559d349-2ffd-492c-e053-2995a90aab06	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Pink Beach	ZINC OXIDE	Tropical Seas, Inc.	d240e6c9-d053-9924-e053-2a95a90a855a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 15	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e49c6f-477b-aafc-e053-2a95a90a982a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559e03b-f5d3-bd72-e053-2995a90a31ca	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30 Clear Zinc	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d128269b-73fa-e5f3-e053-2995a90af1ed	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50 Sport	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e40a7c-b49d-cfc3-e053-2995a90ac27e	2025-11-04	Warnings	Exact identifier application number: M020
Reef Babies SPF 50 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	d5ed3488-aa32-4a63-9996-12c6532c3a4d	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559499c-6109-bf5e-e053-2995a90a4ac7	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e24ca1-d041-355d-e053-2995a90a3d61	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5570cbd-89f5-65d5-e053-2995a90a54d1	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Azure Blue	ZINC OXIDE	Tropical Seas, Inc.	d23fe61a-3ffb-59d0-e053-2995a90a59e6	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b55a0bd0-2a32-2977-e053-2a95a90aa142	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	06d43525-86d8-f2d9-e063-6394a90afc81	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Pacific Purple	ZINC OXIDE	Tropical Seas, Inc.	d240fe7c-9d16-78c9-e053-2a95a90a763c	2025-11-04	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