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 267 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f5a006d1-e957-4063-9b45-2874a1445a33	2024-11-11	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6943a531-c4e7-4e98-9970-3a30b9681b7b	2024-11-11	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a74102d3-b535-4419-8e21-e961980e489d	2024-11-11	Warnings	Exact identifier application number: M020
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50	TITANIUM DIOXIDE AND ZINC OXIDE	DARPHIN DIST.	91277514-4db0-4b40-b95a-3530cac711df	2024-11-11	Warnings	Exact identifier application number: M020
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Aveda Corporation	dfa84bcc-a9b4-426d-8733-35f58c40e94d	2024-11-11	Warnings	Exact identifier application number: M020
SPF30 SUPER SENSITIVE SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	fef47045-1d3c-4f08-acec-e96abefbc261	2024-11-08	Warnings	Exact identifier application number: M020
Mele	NO SHADE SUNSCREEN OIL	CONOPCO Inc. d/b/a Unilever	bd969eab-1da6-76a8-e053-2995a90a5c47	2024-11-07	Warnings	Exact identifier application number: M020
Vaseline Men plus Care Hydrate Face	AGING CHEST AND NECK RESCUE TREATMENT CREAM	CONOPCO Inc. d/b/a Unilever	bd0a9f3c-eaa9-47d0-e053-2995a90ab617	2024-11-07	Warnings	Exact identifier application number: M020
Vaseline	AGING CHEST AND NECK RESCUE TREATMENT CREAM	CONOPCO Inc. d/b/a Unilever	bd965bbc-c9d1-c8da-e053-2995a90a2258	2024-11-07	Warnings	Exact identifier application number: M020
St. Ives Men plus Care Hydrate Face	SOLUTIONS CLEAR SKIN MOISTURIZER SUNSCREEN	CONOPCO Inc. d/b/a Unilever	bcbaaa15-479d-b130-e053-2a95a90afa3b	2024-11-07	Warnings	Exact identifier application number: M020
Dove Men plus Care Hydrate Face	AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE	CONOPCO Inc. d/b/a Unilever	5c28d679-3f92-49e3-8bef-de1c3870f009	2024-11-07	Warnings	Exact identifier application number: M020
Mele Men plus Care Hydrate Face	NO SHADE SUNSCREEN OIL	CONOPCO Inc. d/b/a Unilever	bb2921bc-8892-1db2-e053-2995a90ae28c	2024-11-07	Warnings	Exact identifier application number: M020
Ponds	REJUVENESS ANTI-WRINKLE DAILY MOISTURIZER WITH SUNSCREEN SPF 30	CONOPCO Inc. d/b/a Unilever	736ee790-99f7-686c-e053-2a91aa0ad16e	2024-11-07	Warnings	Exact identifier application number: M020
Mele Men plus Care Hydrate Face	DEW THE MOST SHEER MOISTURIZER SUNSCREEN	CONOPCO Inc. d/b/a Unilever	bb27185b-5732-a648-e053-2a95a90aa930	2024-11-07	Warnings	Exact identifier application number: M020
Ponds	CLARANT B3 EVEN SKIN TONE DAILY MOISTURIZER WITH SUNSCREEN SPF 30	CONOPCO Inc. d/b/a Unilever	736ee790-9a15-686c-e053-2a91aa0ad16e	2024-11-07	Warnings	Exact identifier application number: M020
Byoma Ultralight Face Fluid SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BYOMA LIMITED	2657bca4-bdc7-d959-e063-6394a90a2aa1	2024-11-07	Warnings	Exact identifier application number: M020
Byoma Ultralight Face Fluid SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BYOMA LIMITED	2658df86-8cbb-83dd-e063-6394a90ac4e8	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	547388c6-378b-488b-89d1-c77ebc5d2ed8	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 SUMMER BLEND SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	9641b71a-81f2-4157-801b-162188392a91	2024-11-07	Warnings	Exact identifier application number: M020
SPF30 SUPER SENSITIVE SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	d79cf2d9-4923-452a-bb44-67e059ee37ee	2024-11-07	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