TiZO Photoceutical AM Replenish - Tinted

Product NDC: 58892-101
Requested package NDC: 58892-101-15
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 152 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BINDA Face and Body Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	386f5013-430c-e07f-e063-6394a90a32a8	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452bcb25-848c-e8a7-e063-6394a90ace0f	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452bd1d2-6a9f-f5e8-e063-6394a90ac9e3	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Butter SCREEN SPF 30 sunscreen Butter	HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452bd24d-8654-e6c0-e063-6394a90a0aea	2025-12-04	Warnings	Exact identifier application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen Butter	HOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452bd69e-02c7-fcbd-e063-6394a90ae59b	2025-12-04	Warnings	Exact identifier application number: M020
Softlips Cherry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bececc42-1321-430a-80ef-438060fdcc86	2025-12-04	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip Balm SPF 15 Watermelon	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450d038b-3f99-add8-e063-6294a90aee9a	2025-12-03	Warnings	Exact identifier application number: M020
Natrience Broad Spectrum SPF 30	SKIN SHIELD	Sisel International, LLC	1989370f-68a6-6f22-e063-6394a90aacaf	2025-12-03	Boxed warning, Warnings	Exact identifier application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 Coconut	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450d8fd0-20ad-1920-e063-6394a90a7271	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 Exotic	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450db2bb-1788-efc2-e063-6294a90a13c0	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 Watermelon	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450dcc02-8bcb-6c07-e063-6394a90a5df4	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	44acf513-ffe6-888c-e063-6394a90a9c5c	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450e52a9-5a6b-112f-e063-6394a90af7ca	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 Unscented	ZINC OXIDE	9055-7588 Qubec Inc.DBA ATTITUDE	450e6eb7-f49e-296e-e063-6294a90a05a4	2025-12-03	Warnings	Exact identifier application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango	ZINC OXIDE	9055-7588 Qubec Inc. DBA Attitude	359a7ebf-46a6-4e99-b43c-f585e9bc08d9	2025-12-03	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d95a2b7-288d-7b29-e063-6294a90ae46b	2025-12-03	Warnings	Exact identifier application number: M020
Attitude - Lip Balm - SPF 15 - Coconut	ZINC OXIDE	Attitude DBA 9055-7588 Qubec Inc.	068af2ec-a666-45bf-b0e0-89d1b93dedf1	2025-12-03	Warnings	Exact identifier application number: M020
Cancer Council Invisible Fluid SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1629b02b-e9f3-0593-e063-6294a90a9aa5	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	16994959-cade-06de-e054-00144ff88e88	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	66bb06fb-33d2-4b57-a65f-66bcd187c627	2025-12-03	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	Sample	Exclude flag	Status
58892-101-15	58892010115	1.5 g in 1 PACKET (58892-101-15)	1.5 g	2019-07-23	Yes	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