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 337 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum Sunscreen	ENSULIZOLE, OCTINOXATE, ZINC OXIDE	Amway Corp	6aaec5a4-701e-4870-896d-f68f62448c7a	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen	TITANIUM DIOXIDE	Amway Corp	a83f1192-c6c7-4145-b5af-29202191db78	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Buff L1W1	TITANIUM DIOXIDE	Amway Corp	cba2462d-71ec-4ecb-b05a-5208ff8e22ad	2023-10-21	Warnings	Exact identifier application number: M020
ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 Sunscreen	OCTINOXATE, OXYBENZONE	Amway Corp	8cde14ae-b886-4bd2-b2bd-db604373984a	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1	TITANIUM DIOXIDE	Amway Corp	19d08a86-5a60-4633-8a3c-96bab9a17fcc	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1	TITANIUM DIOXIDE	Amway Corp	d17b1d46-478e-4f48-8fde-ac639bcdc492	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chiffon L2C1	TITANIUM DIOXIDE	Amway Corp	750ca57c-e8e9-4be0-84b1-7f55487f7bf6	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cream L1W2	TITANIUM DIOXIDE	Amway Corp	192dac09-2887-4622-b3d4-c6a9c16b4f88	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Mink L6W1	TITANIUM DIOXIDE	Amway Corp	af6d38d5-69ab-4d7e-b534-b2c2bcf36847	2023-10-21	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Ochre L2N1	TITANIUM DIOXIDE	Amway Corp	7f545d32-b38c-4f6a-a413-7f29e1aa2bc3	2023-10-21	Warnings	Exact identifier application number: M020
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER	AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	2e9463df-1c71-465f-9820-6cedefe07ad7	2023-10-20	Warnings	Exact identifier application number: M020
EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	CLINIQUE LABORATORIES LLC	2ccf568b-b8ff-414d-b15d-0cab6a57a801	2023-10-20	Warnings	Exact identifier application number: M020
CL EB MATTE MAKEUP BROAD SPECTRUM SPF 15	ZINC OXIDE AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	082b297e-d1d9-16b2-e063-6294a90a2ffd	2023-10-20	Warnings	Exact identifier application number: M020
Farmasi BB Cream LIGHT to MEDIUM 02	TITANIUM DIOXIDE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	062ffd88-2016-3c4d-e063-6394a90a5cf9	2023-10-20	Warnings	Exact identifier application number: M020
Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30	ZINC OXIDE	USANA Health Sciences, Inc.	c10c188c-66e0-18ec-e053-2a95a90a5a7d	2023-10-19	Warnings	Exact identifier application number: M020
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATION	AVOBENZONE, HOMOSALATE, AND OCTISALATE	CLINIQUE LABORATORIES LLC	b0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be0	2023-10-19	Warnings	Exact identifier application number: M020
CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE, ZINC OXIDE	CLINIQUE LABORATORIES LLC	884abba1-891d-4c3c-b203-38a5a8a57756	2023-10-19	Warnings	Exact identifier application number: M020
MARA Algae Zinc Sea Kale Sunscreen Serum SPF 30	ZINC OXIDE	Mara Beauty LLC	ba986280-eea3-b49c-e053-2995a90a3957	2023-10-19	Warnings	Exact identifier application number: M020
Valmont Daily Veil. Moisturizing Face Fluid Mineral Sunscreen	ZINC OXIDE	Innovation Labs, Inc.	87a4b9c0-c33d-4bde-b455-dc8c33d8bb9c	2023-10-18	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALM	Raining Rose	efe25551-777c-5336-e053-2a95a90a5c23	2023-10-18	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