TiZO Photoceutical AM Replenish Non-Tinted

Product NDC: 58892-107
11-digit product format: 588920107
Labeler code: 58892
Product ID: 58892-107_26e7189b-149f-97c4-e063-6394a90a0294
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: 2018-03-05
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 Non-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
c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-107-50	TiZO Photoceutical AM Replenish Non-Tinted	50 g in 1 TUBE	CREAM	50	3
58892-107-50	TiZO Photoceutical AM Replenish Non-Tinted	1 in 1 CARTON	CREAM	1	3
58892-107-05	TiZO Photoceutical AM Replenish Non-Tinted	5 g in 1 TUBE	CREAM	5	1
58892-107-15	TiZO Photoceutical AM Replenish Non-Tinted	1.5 g in 1 PACKET	CREAM	1.5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20241121_c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6.zip
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250202_2cb77125-ff77-2060-e063-6294a90ab69f.zip
58892-107	TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]	1	Current NDC, Legacy NDC, 1 package rows	20250212_2cc62961-dcef-d7db-e063-6394a90a9ebd.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 197 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen Broad Spectrum SPF 25	ZINC OXIDE	Earth Mama Angel Baby, LLC	2aa44439-663a-400b-b432-e2dc5ac2a3d1	2025-08-12	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40	ZINC OXIDE	Earth Mama Angel Baby, LLC	afc88e77-a4a1-49ec-b021-bb468fd0ac68	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	31049b45-0f5e-58b6-e063-6394a90ae52c	2025-08-12	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40	ZINC OXIDE	Earth Mama Angel Baby LLC	bd71a814-c0b4-428b-987e-72f7f55f998f	2025-08-12	Warnings	Exact identifier application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40	ZINC OXIDE	Earth Mama Angel Baby, LLC	e9a88a57-5733-489d-a459-dd74c04daff2	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1ddae545-99db-144b-e063-6294a90adae5	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3aa05afb-c843-f38f-e063-6294a90a1cdf	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Sun Bum, LLC	390c6afd-e2be-414c-e063-6294a90ae119	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c32d2c0-0dbe-42e3-e063-6294a90aa993	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c342e57-cf85-b423-e063-6394a90a61b9	2025-08-12	Warnings	Exact identifier application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	8e284afd-b90f-41d5-b334-e5cf4440b4d3	2025-08-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 22N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ad8afa83-2844-422c-b2bf-b5a61be368b1	2025-08-11	Warnings	Exact identifier application number: M020
ScarAid SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3c19063a-cdde-1bbe-e063-6294a90aa8a2	2025-08-11	Warnings	Exact identifier application number: M020
Pro-Sil SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3be06f82-935d-b1c2-e063-6294a90a953c	2025-08-11	Warnings	Exact identifier application number: M020
Curology Daily Moisturizing	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Curology, Inc	3c1967fc-bb89-2f7e-e063-6394a90a2512	2025-08-11	Warnings	Exact identifier application number: M020
ScarAid US SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3c196fa4-1bd3-7a43-e063-6294a90a4fb7	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	96973dee-681b-4c5d-b31f-de05cd79fa18	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ecda3658-eca1-48c2-9eff-e22fd1ff70df	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	968abacd-8b99-4529-a627-2b56cdf99e1b	2025-08-11	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
58892-107-05	58892010705	5 g in 1 TUBE (58892-107-05)	5 g	2019-07-23		Yes	No	Current
58892-107-15	58892010715	1.5 g in 1 PACKET (58892-107-15)	1.5 g	2019-07-23		Yes	No	Current
58892-107-50	58892010750	1 TUBE in 1 CARTON (58892-107-50) / 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	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	2025-01-27	HUMAN OTC DRUG LABEL	1
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-11-14	HUMAN OTC DRUG LABEL	3