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 32 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MELAO TALLOW SUNSCREEN	ETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATE	Guangzhou Haishi Biological Technology Co., Ltd.	519d9f52-b704-d6cd-e063-6294a90a6e42	2026-05-13	Warnings	Exact identifier application number: M020
Hampton Sun SPF30 Mineral	ZINX OXIDE	S&C Hampton Sun LLC	019b0c1a-f9f3-4756-8b24-35bf4dc4aa22	2026-05-13	Warnings	Exact identifier application number: M020
Standard Procedure SPF 50 Sunscreen Face and Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories	34f6150d-9627-94a5-e063-6394a90ad448	2026-05-13	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	defa9588-95be-4f5c-86bb-53d6a1df7f5f	2026-05-13	Warnings	Exact identifier application number: M020
MELAO TALLOW SUNSCREEN	ETHYLHEXYL METHOXYCINNAMATE	Guangzhou Haishi Biological Technology Co., Ltd.	22982b28-37df-ed81-e063-6394a90a77db	2026-05-12	Warnings	Exact identifier application number: M020
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D Technology	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Frase Skin PTY LTD	d904fd23-a3a1-4564-8eec-13a4c96e23f7	2026-05-12	Warnings	Exact identifier application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50	ZINC OXIDE	Caribbean Sol International, LLC	24678326-547f-427d-a481-d8c40380e30a	2026-05-12	Warnings	Exact identifier application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50	ZINC OXIDE	Caribbean Sol International, LLC	20aadcf6-16a3-4344-837b-b91ba8753fb0	2026-05-12	Warnings	Exact identifier application number: M020
Cancer Council Daily Face Moisturizer SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1b4333b8-5747-c591-e063-6294a90a9924	2026-05-12	Warnings	Exact identifier application number: M020
Lather Daily Defense Mineral SPF 45 Facial Sunscreen	ZINC OXIDE	Lather, Inc.	50c732a0-b282-d61b-e063-6294a90aa76b	2026-05-12	Warnings	Exact identifier application number: M020
Hampton Sun SPF50 Mineral Face Sunscreen	HOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%	S&C Hampton Sun LLC	f1c5310b-c43b-475d-8a50-d55759ad3164	2026-05-12	Warnings	Exact identifier application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Stellar Beauty Co.	0f7ee8c6-3af2-42a2-b341-3e0da42c7c93	2026-05-11	Warnings	Exact identifier application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology Cool	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Frase Skin PTY LTD	0a5cc927-0fd3-4c8f-b847-a274f6eb09fb	2026-05-11	Warnings	Exact identifier application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen	ZINC OXIDE	Miami Beach Bum	3b778530-9af0-48eb-bd91-d9ac99f2983f	2026-05-11	Warnings	Exact identifier application number: M020
Walgreens SPF 60 Melt-in Milk Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walgreens	345955ea-f37a-8629-e063-6294a90aa7cc	2026-05-11	Warnings	Exact identifier application number: M020
DERMATONE SPF50 Sunscreen	AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%	Dermatone Labs LLC	4dc81593-4790-403f-9d49-6569bcd0fea2	2026-05-11	Warnings	Exact identifier application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Bella Medical Products LLC	518f69fc-fd39-8195-e063-6294a90a3fdd	2026-05-11	Warnings	Exact identifier application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen	RADICAL RESCUE SPF 30 MINERAL SUNSCREEN	ProTransit, Inc.	38e0139c-bb87-55ba-e063-6294a90a82ee	2026-05-11	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