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 76 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	824c5f13-970e-4e9e-8f2a-2a01973d2e59	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7621ef5-47fc-4ccc-aedd-eac328ace7b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64a29ff8-e24d-4818-9b54-734a0eb2a13f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17a0201b-b797-4e65-838f-1ce8d408a020	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72e2c71a-da1d-497f-a8b7-491cff951c63	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	19d1432a-96b0-4cef-b13e-895dd41b41d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a06c820-ccd8-47ce-8bbf-7e90da92b1de	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	205e195a-fd30-44f7-9294-e701f0f766d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5495ff75-0c83-4491-8af7-4aed7a779d7f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	10bc345d-a5b1-4b70-bfa6-a2d7816904bf	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	30268b6e-d42a-4314-b82f-24f9e81cca2a	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	545c962f-2a59-4d94-8fef-ebdba4127f42	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17c9226b-459c-42fe-ac50-7e26db6b49af	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bf323e10-5479-44b3-b4b9-b8ca6b0f7688	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d6a5133-b847-4ecf-8c33-1cb05aca6b91	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	275be888-2c52-43ed-846a-55525002edcd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c73576a6-dbab-4205-add5-876a060b5022	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ae761ac-df06-4913-a8bf-8ca1be32b5b7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72c45120-6997-4250-b9b4-1cdb762efe1a	2026-01-16	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