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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMAKA Broad Spectrum SPF-42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	32b892fd-c68f-4670-bbaa-0b3de5712849	2023-11-11	Warnings	Exact identifier application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	SKINMETICS INC	4a719986-d1d0-4156-b803-04004b721504	2023-11-11	Warnings	Exact identifier application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9aa24e1f-e338-4947-a437-554fb6b227a2	2023-11-11	Warnings	Exact identifier application number: M020
TIGER BABY Baby Sunscreen SPF-50	ZINC OXIDE	BRICKELL BRANDS LLC	f2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c	2023-11-11	Warnings	Exact identifier application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20	OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	a61e20e4-d5c9-4dc4-a18a-cc88b358d15c	2023-11-11	Warnings	Exact identifier application number: M020
EIGHT SAINTS Chase The Sun SPF-30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c	2023-11-11	Warnings	Exact identifier application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30	ZINC OXIDE	SALES BRAIN HOLDINGS LLC	ec06bc4b-90d6-4b41-9086-f57737a34d91	2023-11-11	Warnings	Exact identifier application number: M020
TRENDY JOHN SPF-32 Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRENDY JOHN LLC	80dccecb-fbb3-4af6-9cb4-6acea733e996	2023-11-11	Warnings	Exact identifier application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	19117321-c37b-4b37-9bd6-7c5c973e2f31	2023-11-11	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Blocked SPF-30 Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	669443a1-7b54-454f-b22f-8cfa9df38bbb	2023-11-11	Warnings	Exact identifier application number: M020
STRYX Daily Moisturizer SPF-30	OCTISALATE, ENSULIZOLE	STRYX MEN, INC.	2bac4348-5b5d-41cc-893e-b9d5c1215ab0	2023-11-11	Warnings	Exact identifier application number: M020
SIMPLI DAY All In One SmartCream SPF 42	ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE	SIMPLI SKIN MD LLC	e5aab0ec-eda2-4073-998a-966202dc2233	2023-11-11	Warnings	Exact identifier application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	3c43fe36-2c24-4859-a262-8af4d3420e47	2023-11-11	Warnings	Exact identifier application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30	ZINC OXIDE	JOYSPRING HOLDINGS LLC	3ca50033-5bcb-4a6d-8aba-a797c5b8d0e9	2023-11-11	Warnings	Exact identifier application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TANCEUTICALS, LLC	8640b971-7c99-4c8f-ac5c-ecdd88b99fe0	2023-11-11	Warnings	Exact identifier application number: M020
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	806b4e40-0e02-424b-80e7-026a211b4dfe	2023-11-11	Warnings	Exact identifier application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed	2023-11-11	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF 50	ZINC OXIDE	Proven Skincare	bb921e91-9faf-4210-9091-ab511af9012a	2023-11-10	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF	ZINC OXIDE	Proven Skincare	f4d682bc-825f-494c-8528-3d328dc63994	2023-11-10	Warnings	Exact identifier application number: M020
Ultra Replenishing Sunscreen SPF 40	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM	CosMedical Technologies, LLC	92ad5d7a-9adb-7d55-e053-2995a90a80e7	2023-11-10	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