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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOU-V SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	YouV, LLC	290cd617-aa90-4f10-8a1d-d8954b927004	2023-11-11	Warnings	Exact identifier application number: M020
BEAST SPIT and POLISH FACE SPF-20	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Small Batch Beauty, LLC	27e5244b-4b69-4dec-9dd5-ba8b71b171b2	2023-11-11	Warnings	Exact identifier application number: M020
SEVEN MINERALS Skin Friendly SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Seven Minerals NA LLC	bd60cf89-e0e9-48ad-b174-1ecf72557d9c	2023-11-11	Warnings	Exact identifier application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	743f3d23-0f5c-4724-9f69-411c109506e1	2023-11-11	Warnings	Exact identifier application number: M020
SEVEN MINERALS Skin Friendly SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Seven Minerals NA LLC	6d6b5b2a-210a-4606-9cdb-f6eec10f37e8	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Baby Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	ac66ad82-a01f-4e44-92a7-b5ab5bd30922	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Daily Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	1745dc35-648e-4315-a285-c99ebeef4f6a	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Face Factor Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	edc2c1e7-e1a8-4b49-96df-8a94eb6a242a	2023-11-11	Warnings	Exact identifier application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Oncoderm, LLC	9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. SPF 50 SPORT	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	The Seaweed Bath Co.	f01516bf-8aed-4402-a3f9-ef11c54d46b3	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. SPF-30	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	The Seaweed Bath Co.	4df55434-fb9a-442d-82cf-16a4957f0a2a	2023-11-11	Warnings	Exact identifier application number: M020
PROJECT REEF Mineral Sunscreen SPF-30	ZINC OXIDE	Project Reef LLC	b7de9ec2-6db1-4c89-b734-15c4bd5c3251	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 Sport	HOMOSALATE, OCTISALATE, ZINC OXIDE	The Seaweed Bath Co.	98ccbb70-6e1a-4e92-a095-cbc4be12fcbf	2023-11-11	Warnings	Exact identifier application number: M020
PROJECT REEF Mineral Sunscreen SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	87b9170c-956e-4aa2-9416-da00cca81b58	2023-11-11	Warnings	Exact identifier application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Youth Corridor	5c0873ff-8e76-48de-919d-f69794c4bd37	2023-11-11	Warnings	Exact identifier application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)	HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE	ZITSTICKA, Inc	32164318-7a7e-40b2-99da-8246c99fdbd3	2023-11-11	Warnings	Exact identifier application number: M020
SUNNY Q Broad Spectrum SPF-30	ZINC OXIDE	Sunny Q Sunscreen LLC	593870fa-425c-401c-ac26-f63f4ce0298f	2023-11-11	Warnings	Exact identifier application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20	OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	44806b83-9220-4d34-806d-20cf0a47186e	2023-11-11	Warnings	Exact identifier application number: M020
BRICKELL Element Defense Moisturizer SPF-45	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	94be278a-3773-469b-8e40-3242d1072a3d	2023-11-11	Warnings	Exact identifier application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Thirty7 LLC	6ff00b6e-1cc7-4cc4-842b-4e379f75e454	2023-11-11	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