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 22 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glow Gloss Lip Balm SPF 40 Vanilla Soft Serve	HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE	Supergoop!	26d2897f-46a7-52b2-e063-6394a90aed32	2026-06-04	Warnings	Exact identifier application number: M020
Epionce Daily Shield Tinted SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Episciences, Inc.	3d1e2921-cba9-4446-e054-00144ff8d46c	2026-06-04	Warnings	Exact identifier application number: M020
Abib No White Cast SPF Gift Set	HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	537420bb-9fd8-0649-e063-6394a90aa8cf	2026-06-04	Warnings	Exact identifier application number: M020
Airy sunstick smooting bar	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	f8203d54-cd3d-314d-e053-6394a90ac10d	2026-06-04	Warnings	Exact identifier application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower Extract	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	0428eebc-4ffb-4981-b738-2c9ecf2a6a2e	2026-06-04	Warnings	Exact identifier application number: M020
Unseen Sunscreen SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Supergoop LLC	21b3491f-7b02-9bc5-e063-6294a90a0dc3	2026-06-04	Warnings	Exact identifier application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden Hour	ZINC OXIDE	Supergoop LLC	1f1be2a7-af96-d73d-e063-6394a90acc1a	2026-06-04	Warnings	Exact identifier application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	975402e6-8c74-b18e-e053-2995a90a467e	2026-06-04	Warnings	Exact identifier application number: M020
Derma E Sun Drops SPF 30	ZINC OXIDE	derma e	76c29f24-e0d9-4235-b278-96e609bc58db	2026-06-04	Warnings	Exact identifier application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GB	ZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5354af18-50c4-5fba-e063-6394a90ace39	2026-06-03	Warnings	Exact identifier application number: M020
ATOMY BB SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b0cd27ee-4917-4800-bcdf-c6e14b28c1d1	2026-06-02	Warnings	Exact identifier application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	ad0b9091-a990-45bf-93f4-d886be1bbffe	2026-06-02	Warnings	Exact identifier application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	994d5680-284e-4faf-a29b-4d28f8d46e8f	2026-06-02	Warnings	Exact identifier application number: M020
BLDG Active Skin Repair Sun Stick Performance Sunscreen	ZINC OXIDE	Innovacyn, Inc.	a751fc1d-5ee4-4ecc-8ade-2568d91890c4	2026-06-02	Warnings	Exact identifier application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE	HOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5347c9a1-2239-b617-e063-6294a90ac601	2026-06-02	Warnings	Exact identifier application number: M020
Sungboon Editor Hydro Booster Moisture Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Olive International Co., Ltd.	4ea2292a-571c-475c-a64c-cbdd1f51f242	2026-06-02	Warnings	Exact identifier application number: M020
Sungboon Editor Daily Invisible Blurring Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Olive International Inc.	42325963-0917-43c4-8fe0-130336c7fa81	2026-06-02	Warnings	Exact identifier application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a8d60212-18a7-42af-8bb3-bfcff7690a49	2026-06-02	Warnings	Exact identifier application number: M020
The Mineral Melt SPF30	ZINC OXIDE, TITANIUM DIOXIDE	Dune Suncare Inc.	2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3	2026-06-02	Warnings	Exact identifier application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	a1acb789-5bf4-4447-b3c5-4a7d4d3013a7	2026-06-01	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