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 297 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY	ZINC OXIDE	Rms organics LLC	1a1aebea-ed0c-ac92-e063-6294a90aeae6	2024-06-04	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only	ZINC OXIDE	SPF Ventures, LLC	1a1bf910-f1bc-bd75-e063-6294a90a663f	2024-06-04	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	0b62062d-b77e-4e6c-b3ab-b35ab24db7cb	2024-06-04	Warnings	Exact identifier application number: M020
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	19b19023-1340-6609-e063-6394a90a6eaf	2024-05-30	Warnings	Exact identifier application number: M020
EltaMD UV Sport SPF50	ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN	CP Skin Health Group, Inc.	dffc3fde-5b6e-4a62-8289-9733be43455b	2024-05-30	Warnings	Exact identifier application number: M020
Vacation by Vacation Scent and Shimmer Duo	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation Inc.	aef8388f-84bb-4e2b-8ae2-aa64f415a632	2024-05-28	Warnings	Exact identifier application number: M020
SPF50 Sunscreen Cariposa	ZINC OXIDE	Talent Brands Company LLC	1938fa13-875a-140e-e063-6294a90a5514	2024-05-24	Warnings	Exact identifier application number: M020
Derma E Vitamin C Weightless Moisturizer SPF 45	ZINC OXIDE	derma e	a3b404a6-e4b1-4c08-a8ef-77446dd2e411	2024-05-24	Warnings	Exact identifier application number: M020
COOLA Classic Liplux Lip Balm SPF 30 Original	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	eeb420f0-c92f-0d96-e053-2a95a90afe36	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee2842c3-65e0-3904-e053-2a95a90aabff	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Mineral Liplux Lip Balm SPF 30 Firecracker	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee026a1c-885b-256f-e053-2a95a90af564	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ec96dee8-85e8-3147-e053-2995a90aaf53	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess	TITANIUM DIOXIDE	COOLA, LLC	eeb406c6-a543-379a-e053-2995a90a4998	2024-05-22	Warnings	Exact identifier application number: M020
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose	TITANIUM DIOXIDE	COOLA, LLC	ee01642f-478e-b307-e053-2a95a90a7d81	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 30 Mineral Sunscreen Coco Mango	ZINC OXIDE	COOLA, LLC	eca9ae89-19dc-516d-e053-2995a90a4698	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Matte Untinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ecabcc89-fb09-41a9-e053-2995a90a8b31	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Matte Tinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee018c21-dca7-28aa-e053-2a95a90a3bdb	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler	ZINC OXIDE	COOLA, LLC	ecaad342-1873-60bc-e053-2995a90a5952	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Shimmer SPF 30 Golden Daze	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eeb70034-0f8d-a46d-e053-2a95a90a8130	2024-05-22	Warnings	Exact identifier application number: M020
Bare Republic Mineral Shimmer SPF 30 Diamond Dust	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eec83ecb-d0ab-7857-e053-2995a90a40ed	2024-05-22	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