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 295 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	01c9c677-9da1-47d9-8b7e-b21f8450c5c3	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	5ab9c228-28e2-43fc-8e0b-7f8e118cb388	2024-06-26	Warnings	Exact identifier application number: M020
SEAWEED BATH CO SPF 40 SPORT	AVOBENZONE, OCTISALATE, OCTOCRYLENE	The Seaweed Bath Co.	d64d4a52-0bea-4bbc-8d34-e16c1b4efe8c	2024-06-26	Warnings	Exact identifier application number: M020
SEAWEED BATH CO Everyday Mineral SPF 40	ZINC OXIDE	The Seaweed Bath Co.	8380bb3f-47d0-4675-b326-620ffb74dbdf	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	be2a83fb-e4f8-4313-b5bd-150f351fb345	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	60689efb-2dd4-4322-a621-54eb2c3c3dc2	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	d8449209-65d0-43c6-8750-0f460a950157	2024-06-26	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	066a0951-2e7e-40c0-8035-4d708a32f16c	2024-06-26	Warnings	Exact identifier application number: M020
GUIDANCE TO GLOW TRU SPF 35	ZINC OXIDE	GUIDANCE TO GLOW SKIN CARE	21b4747b-b173-43c9-b0d4-1dbba5775ff8	2024-06-25	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1bbd14ec-4240-f0c2-e063-6394a90a2c07	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	0200a00f-2b57-454d-933d-a7d48644be6e	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen	ENSULIZOLE	L'Oreal USA Products Inc	8e48e675-0b4f-4b91-85de-c4e29be65147	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	427a21cc-a668-4af8-94cb-b981d5c1919f	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin E	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	451e50a2-2dd7-4c90-88c9-b9f9056d7ee3	2024-06-25	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen	ENSULIZOLE	SICOS ET CIE	979db22b-97eb-4818-aa01-1288b56e38b5	2024-06-25	Warnings	Exact identifier application number: M020
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant	ZINC OXIDE	SQWEEN LLC	b5bf1c4c-7c48-423c-b4fc-52ae57f339fd	2024-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ba50f16-4b76-825f-e063-6294a90a2a4d	2024-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ba57692-c36d-ef4a-e063-6394a90a1236	2024-06-24	Warnings	Exact identifier application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	66a91768-6012-485a-b569-a293ea6d4880	2024-06-24	Warnings	Exact identifier application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	43539766-2e70-4b42-b64b-1d30367b2eb9	2024-06-24	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