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 135 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daily Repair Moisturizing Tinted	ZINC OXIDE	Skintique	37de5a51-0bc4-34ad-e063-6294a90a0eef	2025-12-11		Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	LEILANI VIDAL	36d51157-1bcd-79c8-e063-6394a90aba71	2025-12-11		Exact identifier application number: M020
Mineral Sunscreen	ZINC OXIDE	LEILANI VIDAL	36d4b998-c29c-ff89-e063-6394a90a12d8	2025-12-11		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LEILANI VIDAL	36d5831a-7128-729a-e063-6394a90a8036	2025-12-11		Exact identifier application number: M020
Mineral Matte Non-Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac219bd-dfc8-fe22-e063-6394a90a4a8c	2025-12-11	Warnings	Exact identifier application number: M020
Tinted Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac25d06-d885-48a2-e063-6294a90a0d0b	2025-12-11	Warnings	Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac27b6c-1341-1f05-e063-6394a90a9860	2025-12-11	Warnings	Exact identifier application number: M020
Facial Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	37287e4c-6fdf-62c5-e063-6394a90a1296	2025-12-11		Exact identifier application number: M020
Facial Mineral Sunscreen Non Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	37284de3-32d4-3611-e063-6394a90a6393	2025-12-11		Exact identifier application number: M020
Mineral Lip Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	3728ec6a-7de5-bbc5-e063-6294a90a31b7	2025-12-11		Exact identifier application number: M020
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db5721-2b32-d4d8-e063-6294a90a47d7	2025-12-11		Exact identifier application number: M020
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db14e1-f995-b649-e063-6294a90afd69	2025-12-11		Exact identifier application number: M020
208	ZINC OXIDE	PETER L. KOPELSON, M.D.	351ce033-6bd0-574e-e063-6394a90af448	2025-12-11		Exact identifier application number: M020
208	ZINC OXIDE	PETER L. KOPELSON, M.D.,	351c9727-d7ac-9c3f-e063-6294a90a7721	2025-12-11		Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	MY FAVORITE PLACE SPA LLC	351c0c1e-5712-1e23-e063-6394a90abe6f	2025-12-11		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351d27e3-00d4-8d31-e063-6394a90aaf72	2025-12-11		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351db99e-262f-b67e-e063-6394a90a3418	2025-12-11		Exact identifier application number: M020
Replenishing Daily Protection NT	ZINC OXIDE	MY FAVORITE PLACE SPA LLC	351c5f6f-86e6-7219-e063-6294a90a3745	2025-12-11		Exact identifier application number: M020
Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DAISY'S SKIN TRANSFORMATION LLC	37d9fbf5-d602-d3dc-e063-6394a90abe53	2025-12-11		Exact identifier application number: M020
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374d53a7-be0b-4d7a-e063-6394a90a37c4	2025-12-11		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