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 43 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	cf33c5a1-b7c5-4c5a-9981-e4e24208cd11	2026-04-15	Warnings	Exact identifier application number: M020
JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	56c124d7-0b8c-4bb9-8261-c7395353fbe0	2026-04-15	Warnings	Exact identifier application number: M020
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTES	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	12b64f66-0ec0-4dde-9446-4151ae001ae4	2026-04-15	Warnings	Exact identifier application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, AND OCTISALATE	PML NYC, LLC	396dc7c7-a5e1-e1b2-e063-6294a90a7547	2026-04-15	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Cream	115 N	PML NYC, LLC	316e8ac6-f8fa-7add-e063-6294a90a4f24	2026-04-15	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f8756bf-5b0d-5269-e063-6294a90ae6dc	2026-04-15	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f87e24f-e4ff-03a7-e063-6294a90a23b1	2026-04-15	Warnings	Exact identifier application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo Glow	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cd602-8af5-fbb6-e063-6294a90a287b	2026-04-15	Warnings	Exact identifier application number: M020
Chanvida Broad Spectrum BB Cream	CHANVIDA BROAD SPECTRUM BB CREAM	Guangzhou Ariel Biotech Co., Ltd.	4f8ade09-4f7a-80bd-e063-6394a90a0843	2026-04-15	Warnings	Exact identifier application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Gold Inti Trade Corporation	4f6dd01e-21ab-0aa3-e063-6394a90a51f8	2026-04-14	Warnings	Exact identifier application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMER	BEAUTY PIE U.S.A. INC.	fdefb670-510c-9f1f-e053-6394a90a6a16	2026-04-14	Warnings	Exact identifier application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40	DAILY DOSE BIORETINOL MINERAL SPF 40	PML NYC, LLC	05574910-ddf9-b138-e063-6394a90adc8c	2026-04-14	Warnings	Exact identifier application number: M020
ProtecTINT 20C	HOMOSALATE, OCTISALATE, ZINC OXIDE	PML NYC, LLC	1bcc9f71-820f-eba2-e063-6394a90a3305	2026-04-14	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c0f2d9-3e2f-5358-e053-2995a90aeb84	2026-04-14	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c2a37d-f52d-2fb0-e053-2a95a90a9bfa	2026-04-14	Warnings	Exact identifier application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30	BRIGHTENING SKIN TINT	PML NYC, LLC	f4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc	2026-04-14	Warnings	Exact identifier application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50	NATURIUM DEW-GLOW MOISTURIZER SPF 50	PML NYC, LLC	00c93b11-754e-701c-e063-6294a90a3b1d	2026-04-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-medium	HOMOSALATE, OCTISALATE, AVOBENZONE	PML NYC, LLC	1c3489a6-5b98-2dc2-e063-6294a90a0695	2026-04-14	Warnings	Exact identifier application number: M020
BANANA BOAT	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	4f5896a6-0639-5589-e063-6294a90a45a9	2026-04-13	Warnings	Exact identifier application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4f2c83e4-e656-f81e-e063-6394a90a4c68	2026-04-11	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