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 5 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	5991466a-e729-16b7-e063-6394a90a11ff	2026-08-21	Warnings	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	597b78df-83cb-1b21-e063-6294a90a56a8	2026-08-20	Warnings, Adverse reactions	Exact identifier application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45	HOMOSALATE, OCTISALATE, AVOBENZONE	Stewart Charley Ventures, LLC	2fc45f85-a6f8-4893-8b34-4db5e39cb615	2026-08-20	Warnings	Exact identifier application number: M020
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Concierge Choice LLC	5980055b-493e-4763-e063-6294a90a570f	2026-08-20	Warnings	Exact identifier application number: M020
Lip Balm SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Skin Script, LLC	20c5fde7-ee8f-4b74-e063-6394a90a93ec	2026-08-19	Warnings	Exact identifier application number: M020
Aloe UP .5OZ SPF 50 MINERAL Sunscreen	ZINC OXIDE 14.69%	Aloe Care International, LLC	6ad80af3-78cd-4211-a5f2-68531aae264a	2026-08-19	Warnings	Exact identifier application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick	ZINC OXIDE	Utu Co	596e17d3-3064-1cda-e063-6294a90af963	2026-08-19	Warnings	Exact identifier application number: M020
Mineral sunscreen	MINERAL SUNSCREEN	Guangzhou Origin Beauty Cosmetics Co., Ltd.	59713657-a7ef-1aee-e063-6394a90a326e	2026-08-19	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 14.69%	The Naked Bee	f820a9be-c94d-4fd5-b202-2dda5746a82a	2026-08-18	Warnings	Exact identifier application number: M020
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 20%	The Naked Bee	7dd2b1cd-e229-4eeb-8122-46fde5af1091	2026-08-18	Warnings	Exact identifier application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee52faa-64a8-4bdf-e063-6294a90a65cf	2026-08-17	Warnings	Exact identifier application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	3ee4feb3-6966-67f9-e063-6394a90a16d5	2026-08-17	Warnings	Exact identifier application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier application number: M020
Soleil Defense Sunscreen	BROAD SPECTRUM SPF 30	AMARA MED SPA LLC	594244b1-db3b-002b-e063-6394a90a0329	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier application number: M020
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	Charleston Dermatology, P.C.	59440f7f-4213-6e2b-e063-6394a90af483	2026-08-17	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	CORBY, JR., TERRY L.	594443fd-8e27-4ec6-e063-6294a90a3ff0	2026-08-17	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