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 73 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922e001-e699-7ac5-e063-6394a90a25d9	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	a9350360-7932-459f-806c-399fa265e6c0	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1923067f-1ab9-d168-e063-6394a90adbd0	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922ee84-d7d0-80b1-e063-6394a90acf7b	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	310a07bb-d32a-401f-955e-4c2860148a30	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	39ae4a97-7f96-4c95-a6de-0c779764fb02	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc3e-055c-e51d-e063-6294a90a00f5	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	9c7a31df-5bdd-403b-b807-1d1a801e1bb6	2026-01-20	Warnings	Exact identifier application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One	ZINC OXIDE	Clean Beauty For All, Inc (dba Saie)	1922fc51-ae53-acb8-e063-6394a90a14eb	2026-01-20	Warnings	Exact identifier application number: M020
Wrinkle Repair Moisturizer SPF 30 EQB	AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%	Walmart	a067e968-e598-40ef-95f2-c338b5e413dd	2026-01-20	Warnings	Exact identifier application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Welmedix LLC	48da4589-0f5a-c25b-e063-6394a90ac18b	2026-01-20	Warnings	Exact identifier application number: M020
SPF 50 Mineral Sunscreen Kids	ZINC OXIDE 14.69%	S&C Hampton Sun LLC	0bdb7d15-dc52-4e23-9417-fe73f17f6110	2026-01-20	Warnings	Exact identifier application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK	OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE	DEWYTREE CO. ,LTD	48406e68-eefd-d2c2-e063-6394a90a4ad9	2026-01-20	Warnings	Exact identifier application number: M020
KONEUK SUNSCREEN SPF50	KONEUK SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	48dd7f6e-2a4d-2c92-e063-6294a90a4255	2026-01-20	Warnings	Exact identifier application number: M020
CHUDA	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	Premier Ocher LLC	1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f	2026-01-20	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	12edec55-2414-4bbd-bc96-4599a96b96ac	2026-01-19	Warnings	Exact identifier application number: M020
PROJECT REEF SPF-30 Mineral Sunscreen	ZINC OXIDE	Project Reef LLC	a6077e6f-d987-4159-946f-3e2397247659	2026-01-19	Warnings	Exact identifier application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	86ee2fdf-8a88-44e6-b12a-36a92360477a	2026-01-19	Warnings	Exact identifier application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30	ZINC OXIDE	SABAL SUN LLC	f917b446-4e10-4231-826e-fdac32e11186	2026-01-19	Warnings	Exact identifier application number: M020
Plius Daily SPF Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	PLIUS, Inc	31866de9-afa0-4c11-be65-b61373551493	2026-01-19	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