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 147 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2fb00db0-4c37-56c6-e063-6294a90a8aff	2025-12-08	Warnings	Exact identifier application number: M020
Matte Shield SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE SOLUTIONS NYC INC	3bb582ec-71e7-4ad8-e063-6394a90a94d4	2025-12-08	Warnings	Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334afdc8-1e12-d787-e063-6294a90aed7c	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334bf8ea-2485-84e8-e063-6294a90aefa6	2025-12-08		Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334d694a-f9e4-ae86-e063-6394a90abfe1	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334e32a4-c3a5-e37d-e063-6294a90ad6cf	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245561d-a90c-7bf0-e063-6394a90ab3b6	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245c1f7-2c1b-b6ad-e063-6394a90aaee6	2025-12-08		Exact identifier application number: M020
Mineral Based Facial Sunscreen	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3e8981ed-5847-7009-e063-6394a90a49a1	2025-12-08	Warnings	Exact identifier application number: M020
Replenishing Daily Protection Sunscreen Invisible	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32462e88-0e74-a675-e063-6294a90ac564	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32465271-abb9-d03f-e063-6294a90a990e	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32486bfb-0cc8-0283-e063-6394a90a9967	2025-12-08		Exact identifier application number: M020
Harrys Daily Facial SPF Broad Spectrum	ZINC OXIDE	Harry's, Inc.	39fdde34-45ec-bc22-e063-6394a90a7dce	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Brightening plus Tint	ZINC OXIDE	ZEN DERMATOLOGY, INC.	31e32e9c-9e0b-b678-e063-6294a90a66f5	2025-12-08		Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine plus Tint	ZINC OXIDE	Zen Dermatology, Inc.	31576340-cb11-d944-e063-6294a90adef2	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine - No Tint	TITANIUM DIOXIDE, ZINC OXIDE	Zen Dermatology, Inc.	31572a16-5f60-565f-e063-6394a90ab8c9	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Face and Body	ZINC OXIDE	Zen Dermatology, Inc.	31e376b4-098f-34d7-e063-6394a90a1772	2025-12-08		Exact identifier application number: M020
AcneFix Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	315894b7-ac1b-0982-e063-6294a90ab879	2025-12-08		Exact identifier application number: M020
Shunly Natural Cover SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care	a64e373b-b3f6-4024-b5f5-253783485cd6	2025-12-08	Warnings	Exact identifier application number: M020
AcneFix Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	31583c7e-365a-d899-e063-6394a90aa63f	2025-12-08		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