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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade	SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE	Autumn Harp	fd6807e1-c8c0-b361-e053-6294a90aea0c	2023-06-05	Warnings	Exact identifier application number: M020
Thinksport Clear Zinc SPF 50	ZINC OXIDE	thinkOperations,LLC	b5ce523f-eee8-f1a8-da19-b3dc14f8a58e	2023-05-31	Warnings	Exact identifier application number: M020
Thinksport Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	77b63c0b-353b-4f5f-95c7-6f7eeab81471	2023-05-30	Warnings	Exact identifier application number: M020
Think Kids Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	25c59820-a08d-4abe-87ae-a787ac8b2ac2	2023-05-30	Warnings	Exact identifier application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50	ZINC OXIDE	Topiderm, Inc.	46c6f20f-4bb6-47c6-9eac-17ca97bb14a7	2023-03-20	Warnings	Exact identifier application number: M020
Replenix Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	9223ffa8-7af3-4407-9170-482afec536d8	2023-02-24	Warnings	Exact identifier application number: M020
Bath and Body Works SPF20 Coconut Lip Balm	SPF20 LIP BALM	Autumn Harp	f5744a48-2b39-4949-e053-2a95a90ab15d	2023-02-24	Warnings	Exact identifier application number: M020
Replenix Tinted Sunscreen SPF 50	ZINC OXIDE AND OCTINOXATE	Topiderm, Inc.	1fda4a54-e323-4f3c-b659-bded4b1b3dd0	2023-02-22	Warnings	Exact identifier application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91	2023-02-22	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	3a637542-0f79-47ae-815d-84d0036c737a	2023-02-13	Warnings	Exact identifier application number: M020
Essential Moisturizing Sunscreen	ZINC OXIDE, OCTINOXATE	Topiderm, Inc.	450d916e-4c77-489e-86b1-78b686355476	2023-02-09	Warnings	Exact identifier application number: M020
Mineral Repair SPF 45	ZINC OXIDE	Topiderm, Inc.	84580f10-3119-4253-87a6-53d24a1f2227	2023-02-07	Warnings	Exact identifier application number: M020
Think Aloe and Tea Leaves Zinc oxide	ZINC OXIDE	thinkOperations,LLC	9965ccd1-821d-4d9d-8a56-e87440b809ee	2023-02-02	Warnings	Exact identifier application number: M020
Replenix Lip Therapy homosalate	HOMOSALATE	Topiderm, Inc.	b60dc004-d713-47bc-a6e9-ea4783aa7019	2023-02-02	Warnings	Exact identifier application number: M020
Josie Maran Argan Daily Moisturizer SPF47	ZINC OXIDE, TITANIUM DIOXIDE	Autumn Harp, Inc.	027821e6-db7d-4c03-956a-00313488ebc7	2023-01-14	Boxed warning, Warnings	Exact identifier application number: M020
Tinted Lip Balm SPF30 Wild Peony	SPF30 LIP BALM	Autumn Harp	d0604720-623a-e8a9-e053-2995a90ab0e6	2023-01-10	Warnings	Exact identifier application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a39d91c-2dcf-71d6-e063-6394a90a5474	2022-02-10	Warnings	Exact identifier application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3a63d3-c7e0-bf03-e063-6394a90a1662	2022-02-10	Warnings	Exact identifier application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3c0aa0-7501-7ef0-e063-6294a90a9f94	2022-02-10	Warnings	Exact identifier application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35	OCTINOXATE AND OXYBENZONE	Groupe Marcelle Inc.	c24ac3ad-b2e2-4381-bd80-a499da0e0670	2021-12-14	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