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 226 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sum 37 Micro Active Daily Moisture Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2eea94e1-2409-8ad6-e063-6294a90a5df8	2025-03-03	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21c9f9-acf8-997b-e063-6394a90ada3f	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e232e8d-4274-68bc-e063-6394a90a942b	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e23d463-fbc1-5718-e063-6294a90a7272	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e24391f-4982-efae-e063-6394a90accaa	2025-03-01	Warnings	Exact identifier application number: M020
FRUDIA Blueberry Hydrating Air Fit Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	WELCOS CO.,LTD.	8b2a1baa-e528-48d6-9cd8-c3cb55e0641b	2025-02-28	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f1b5454-8bf5-b447-e063-6394a90a743a	2025-02-27	Warnings	Exact identifier application number: M020
Clear Defense SPF 45	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	d681d92f-3501-4fca-b629-096341f20ab1	2025-02-27	Warnings	Exact identifier application number: M020
HA Physical Tint SPF 44	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a5e19d77-703e-41e0-9a02-19227dc6c819	2025-02-27	Warnings	Exact identifier application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Private Label Skin Care	18444581-66a4-4eda-a8df-627fa3b4b98a	2025-02-26	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL	ZINC OXIDE/TITANIUM DIOXIDE	SPF Ventures, LLC	2f069114-9ca8-aed4-e063-6394a90a46d8	2025-02-26	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Cream	230 N	Melaleuca Inc.	2f133abb-cad2-2ac8-e063-6294a90aa480	2025-02-26	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f17b5fe-44da-964b-e063-6394a90ae699	2025-02-26	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2efb73a6-601d-61a4-e063-6294a90af825	2025-02-25	Warnings	Exact identifier application number: M020
Rida Hair Research Institute	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Rida LLC	ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 70 Peach Blossom	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed217698-f552-677e-e053-2995a90acb0a	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Tropical Coconut	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed0f8249-aba8-b67c-e053-2a95a90af7eb	2025-02-25	Warnings	Exact identifier application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	f176c1b1-f539-417f-98b5-69d99365f2f2	2025-02-25	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2ee82379-6609-fd8e-e063-6294a90acf6c	2025-02-24	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f2780cb5-063c-10d3-e053-2995a90a8576	2025-02-24	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