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 179 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Curology The Lip Balm Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Curology Inc.	e441b13f-cb58-457f-e053-2a95a90adab9	2025-10-15	Warnings	Exact identifier application number: M020
Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defense	ZINC OXIDE	Curology	39a2a297-3af2-40d3-8b5d-f4eef2487fb2	2025-10-15	Warnings	Exact identifier application number: M020
Colorescience Total Protection No Show Mineral Sunscreen	ZINC OXIDE	Colorescience	00d8bf32-aecd-22da-e063-6294a90a7567	2025-10-15	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand	ZINC OXIDE	Cosmetic Enterprises Ltd	253c105b-215b-1e6e-e063-6294a90a11d7	2025-10-14	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan	ZINC OXIDE	Cosmetic Enterprises Ltd	265bbb1a-ba96-6598-e063-6394a90a9415	2025-10-14	Warnings	Exact identifier application number: M020
Resist Wrinkle Defense SPF 30 Paulas Choice	ZINC OXIDE	Cosmetic Enterprises Ltd	d658fdc7-9dac-47bf-8e83-1433a29a6cf6	2025-10-14	Warnings	Exact identifier application number: M020
SPF 50 Face Sunscreen Bioelements	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Cosmetic Enterprises Ltd	498b16c8-ba54-4a0a-8dbc-4b5cc368e214	2025-10-14	Warnings	Exact identifier application number: M020
Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas Choice	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE	Cosmetic Enterprises Ltd	3bf31626-5580-457b-8a59-cc37f4ab0767	2025-10-14	Warnings	Exact identifier application number: M020
Sunscreen Broad Spectrum SPF 30 Light Tropical Scent	ZINC OXIDE	Cosmetic Enterprises Ltd	d8c7b82d-6151-2199-e053-2a95a90a6c20	2025-10-14	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	412975d8-0b8b-23bf-e063-6294a90a5568	2025-10-14	Warnings	Exact identifier application number: M020
TOCOBO Bio Watery Sun Screen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	4129e00b-951d-adbf-e063-6294a90a675e	2025-10-14	Warnings	Exact identifier application number: M020
Sunny Sailor First Mate Face Stick SPF 30	ZINC OXIDE	SUNNY SAILOR LLC	c7908385-ff93-4c6c-9462-081c73023571	2025-10-13	Warnings	Exact identifier application number: M020
Cloud Brush On Sunscreen SPF 50	ZINC OXIDE	FUTURE 8 LLC	8b1eaf6c-9cd8-4c5e-beac-b8539c332ae3	2025-10-13	Warnings	Exact identifier application number: M020
Sunplus Mist Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	951a7bdc-d5c5-4241-a482-c30a4b44f776	2025-10-13	Warnings	Exact identifier application number: M020
Sunplus Mist Sunscreen SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	da338ba7-7a92-4157-97f4-5ae9cc64853c	2025-10-13	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 50 Alcohol Free Sunscreen	OCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	998fe524-6469-4c9b-889b-3191882149ce	2025-10-13	Warnings	Exact identifier application number: M020
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE , ZINC OXIDE	Skinlycious Pte Ltd	e0ad02c3-f5ed-4b72-ba96-07d9c489a4ea	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff	ZINC OXIDE	Cosmetic Enterprises Ltd	265bc5e0-0a2a-842e-e063-6394a90aae0a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha	ZINC OXIDE	Cosmetic Enterprises Ltd	2748b6bc-e80b-ce66-e063-6394a90a400a	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze	ZINC OXIDE	Cosmetic Enterprises Ltd	265bf123-c4c3-8414-e063-6394a90a4730	2025-10-13	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