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 190 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 38C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	0358a87d-8002-4f3e-851a-3a582d356edf	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	34dfc4c5-44f7-4531-97ba-8846ebe14724	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	cf4b6f45-d4ae-4665-87b4-c5af4910befa	2025-09-03	Warnings	Exact identifier application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	DOLCE & GABBANA BEAUTY SRL	eb63e9c6-bdb0-4bdf-8822-e4561a56adc9	2025-09-03	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N Light	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9507681c-236c-41c1-9dc9-ed4c0c091741	2025-09-03	Warnings	Exact identifier application number: M020
Pure6 ManiShield Hand Screen	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3abcb6ba-1de8-55e7-e063-6294a90aecf1	2025-09-02	Warnings	Exact identifier application number: M020
Round Lab Dodo s Pick Bestseller Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	3dd3db99-2e9f-16fc-e063-6294a90adda1	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - Pegged	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d86da52-6354-f53e-e063-6394a90aac55	2025-09-02	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Baxter Laboratories Pty	3dd711c1-7758-31da-e063-6294a90a4f38	2025-09-02	Warnings	Exact identifier application number: M020
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3dd7b0af-dc37-1701-e063-6294a90a65c3	2025-09-02	Warnings	Exact identifier application number: M020
toty Ilumina CC Creamy Compact 6N	TITANIUM DIOXIDE	Chipican LLC	3da732e7-19b0-3195-e063-6394a90a9a0c	2025-09-01	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4	ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dba1360-f70f-e450-e063-6394a90a8c9f	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7e7ef4-c3ac-4c26-e063-6394a90a9e42	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	3a7db6f4-66fd-4473-e063-6394a90a886e	2025-09-01	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	2f7eb413-ff49-711d-e063-6394a90ad6dc	2025-09-01	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3db1cf3e-0640-6821-e063-6294a90a7036	2025-08-31	Warnings	Exact identifier application number: M020
Purpose Dual Treatment SPF 10	OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%	Elysium Consumer Healthcare LLC	3d7fe711-a671-df30-e063-6394a90afbbf	2025-08-29	Warnings	Exact identifier application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30	ZINC OXIDE	Good Weather Inc.	3d83aaa5-0e4e-928a-e063-6294a90a24da	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e249507c-d536-4c1d-a99d-857ca1e833d8	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ba99edea-bf68-4118-8bb7-ea40322db46a	2025-08-29	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