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 194 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	3ccd2703-c410-74b7-e063-6294a90a7f88	2025-08-20	Warnings	Exact identifier application number: M020
SEYE	ZINC OXIDE AND TITANIUM DIOXIDE CREAM	Guangzhou Seye Biomedical Technology Co., Ltd.	3cce91b1-311b-4c95-e063-6294a90a2d7a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3ccfb90a-5976-4b38-e063-6294a90a123a	2025-08-20	Warnings	Exact identifier application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cd3ce69-becc-41b7-e063-6394a90a2782	2025-08-20	Warnings	Exact identifier application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Obagi Cosmeceuticals LLC	4838679b-f510-440b-8670-a10c05ebed9b	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 New	ZINC OXIDE	Sun Bum, LLC	3b8e1d73-b023-cfbd-e063-6294a90ae29d	2025-08-19	Warnings	Exact identifier application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-Free	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	8de31db2-46cf-7178-e053-2995a90a5024	2025-08-19	Warnings	Exact identifier application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cbcae23-9b38-edaa-e063-6294a90a2e8f	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30	ZINC OXIDE	Sun Bum, LLC	3cbeb4ce-6d7c-387c-e063-6394a90af790	2025-08-19	Warnings	Exact identifier application number: M020
Olay Total Effects Moisturizer Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	8de52cb2-b4d2-1e0d-e053-2995a90a5aca	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen Lip Balm	ZINC OXIDE	Sun Bum, LLC	3cbfba65-5702-50b5-e063-6394a90a409d	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50	ZINC OXIDE	Sun Bum, LLC	324e8ddb-89d2-08ca-e063-6294a90ab6c1	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b02811d-dc66-fc6f-e063-6294a90aefc8	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b058b74-27d0-8f8a-e063-6294a90aa02c	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit Extract	ZINC OXIDE	Supergoop LLC	3ca7e1ed-7cc7-76b0-e063-6394a90ade93	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZ	ZINC OXIDE	Sun Bum, LLC	3b91a7e3-ce52-6aa0-e063-6394a90a15e7	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca8742f-67cb-a25c-e063-6394a90a4638	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b154009-9c6f-eadf-e063-6394a90ae424	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b162348-0222-490e-e063-6394a90ad494	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b169860-66bc-dd02-e063-6294a90a7974	2025-08-18	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