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 104 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THE MELT MIST Sheerest Mineral Mist Suncare for Body	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	465d3277-7798-512a-e063-6294a90a2065	2025-12-20	Warnings	Exact identifier application number: M020
THE SLIP Invisible Cooling Suncare for Face and Body	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	465e1ba2-e967-edb9-e063-6294a90aa31c	2025-12-20	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7287078e-67ff-41fe-bc8d-59b2146f5dc9	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6095639-e2ee-418e-b4f1-e59da1bd9216	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8c6466a6-4f11-4210-bb02-eb31c15984cd	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	07f8282b-047b-4be1-8779-39ed5dd6fb5d	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a8c67c1-aeba-490d-8347-a30916efcf3b	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	739450b0-8cd7-41de-8cd0-1827e02478c6	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	08b0e056-583a-474b-aaaa-ecea05703044	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a89af40e-cf45-4afc-aac7-5f71a05bcd3f	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6da72e20-f2d7-492e-9b65-b5ac73bc0029	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	de615c3e-669f-493c-9c75-73dfbe726c59	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	152790ba-aeda-4c2a-b725-7e040e832883	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c87e5201-f7fd-4fd9-adeb-d6af9be00db6	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84cdaad2-5b7d-4841-bef6-ffad4fe6907a	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b4caa2bc-8118-4137-8834-25800f8e5e01	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c0fa32fe-faa7-4a47-906c-14db01e55d47	2025-12-19	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ff1a8b32-c01f-4910-9a7a-c74eb49c05a0	2025-12-19	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