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 195 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum 50 Premium Moisturizing Sunscreen Roll-On	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c58c9c7-ca9e-d012-e063-6394a90a5aa9	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a003d82-90bd-f541-e063-6394a90ac906	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a00e4fb-6bf2-4c44-e063-6294a90a61bf	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a0f99df-e6c0-71d9-e063-6294a90a4c9e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	ZINC OXIDE	Sun Bum, LLC	3a13d4f1-c158-7fa0-e063-6294a90a6fb4	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen Face Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3a147fe1-0dda-5433-e063-6394a90a1a59	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Sunscreen Browning	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c5b0db8-f05a-2b5c-e063-6294a90ae79b	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3aaf7d28-b306-b416-e063-6294a90a021e	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a263b85-e7a0-c068-e063-6294a90a49f2	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen Roll-On	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a392237-019d-2384-e063-6394a90a5b24	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Bonfire	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3a3b3b4a-148c-1dc5-e063-6394a90a7bdb	2025-08-14	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac48eef-f651-af96-e063-6294a90a501e	2025-08-14	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	6a398dad-2fb9-4cdb-86c5-2a392b88f29b	2025-08-13	Warnings	Exact identifier application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40	ZINC OXIDE	ALL THE RAJE, LLC	9ffbd53b-1295-42b4-9cd5-18cbb75921d0	2025-08-13	Warnings	Exact identifier application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre	ZINC OXIDE	Power Beauty Co.	2e6eac42-0b70-44ea-e063-6294a90a49f8	2025-08-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE/OCTOCRYLENE/OXYBENZONE	Edgewell Personal Care Brands LLC	3c414e9b-6c3e-2c8d-e063-6394a90af4a6	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c443347-0134-8c87-e063-6294a90a8046	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3a22f0b9-2d6d-6230-e063-6294a90adf31	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c4567d6-879e-f995-e063-6394a90a319f	2025-08-13	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c457455-b9b1-546b-e063-6294a90a41f6	2025-08-13	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