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 44 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRUST MD SPF30 STEM CELL FACE	OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE	Guangzhou Yapheon Health Industry Co., Ltd.	4f2ca12c-bc6f-61b8-e063-6294a90a0d7e	2026-04-11	Warnings	Exact identifier application number: M020
MIDHA Rice Daily Moisture Sun Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MIDHA Cosmetic Co.,Ltd.	4b394107-7830-c2c6-e063-6294a90a07d9	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Deep	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f15d5ba-6396-56bf-e063-6394a90adb06	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Light	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f165895-aa84-e215-e063-6394a90a6256	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Medium	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f16b8a4-4279-5f79-e063-6294a90a353d	2026-04-10	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	f5ca0416-548c-4be0-a69e-c7e1b52aba95	2026-04-10	Warnings, Adverse reactions	Exact identifier application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT	ZINC OXIDE	The Green Cricket Inc	c56fd135-f46a-51ce-e053-2a95a90ab7b3	2026-04-10	Warnings	Exact identifier application number: M020
CorTex SunX 50 Thick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	f67a6c6c-c314-1c9d-e053-2a95a90a7f1a	2026-04-10	Warnings	Exact identifier application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18	OCTINOXATE AND ZINC OXIDE	NSE Products, Inc.	b9635e59-bb08-4167-b7ba-54c3fc712589	2026-04-09	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	79c6fe2a-34c2-44cc-81bc-796c4463d2a6	2026-04-09	Warnings, Adverse reactions	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdbae5-84ec-7b1d-e063-6294a90a2878	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15	SUNSCREEN LIP BALM	Arizona Sun Products	11e9cb25-6ff8-a121-e063-6394a90a849e	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 8	SUNSCREEN	Arizona Sun Products	11e8b612-29be-47ed-e063-6394a90ab9e7	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdcfd0-8b24-7efc-e063-6294a90af7fa	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Cycleblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e71a84-12d1-2d4f-e063-6294a90adcd6	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Bikerblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e6eafd-f967-b748-e063-6394a90aabfd	2026-04-09	Warnings	Exact identifier application number: M020
YSE Beauty Skin Glow Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MSS Beauty LLC	6a318e27-14e5-488e-ac19-010f69cb743d	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30	SUNSCREEN	Arizona Sun Products	116ed17c-3b38-5e96-e063-6294a90a4246	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Surfblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e76815-9316-555d-e063-6294a90aeb81	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Moisturizer SPF 3	MOISTURIZER	Arizona Sun Products	1171af26-3040-552c-e063-6294a90ae220	2026-04-09	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