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 151 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poolside Clear Intentions Invisible Face Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451b902d-892d-15f1-e063-6294a90a3024	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla Icing	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451ba227-7973-1378-e063-6294a90ae893	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink Ice	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451ba704-6fbd-d5a0-e063-6394a90a2fbc	2025-12-04	Warnings	Exact identifier application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic Twist	HOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451bb62e-b603-7663-e063-6294a90a46db	2025-12-04	Warnings	Exact identifier application number: M020
Prequel Lip Visor SPF 30 ROSEDUST	LIP 30 CLEAR	The Center Brands, LLC	33d5e1ad-ba7a-25f8-e063-6294a90aa38e	2025-12-04	Warnings	Exact identifier application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen Serum	BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE	Everyday Group Limted	54f8aca8-fbbc-498a-aaf8-aee716511dde	2025-12-04	Warnings	Exact identifier application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch Sunscreen	BUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE	Everyday Group Limted	48e70326-ecf7-44c9-a4cc-2044bd6a6415	2025-12-04	Warnings	Exact identifier application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTED	ZINC OXIDE	Reve Skincare LLC	35f5652f-3e6b-71c9-e063-6294a90a9e86	2025-12-04	Warnings	Exact identifier application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTY	ZINC OXIDE	Reve Skincare LLC	35f4dd1b-c3d9-8408-e063-6394a90a7914	2025-12-04	Warnings	Exact identifier application number: M020
Activated Mineral Sunscreen Tinted	ACTIVATED MINERAL SUNSCREEN TINTED	Reve Skincare LLC	312a32a7-d253-f10c-e063-6294a90a803a	2025-12-04	Warnings	Exact identifier application number: M020
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30	LIP BALM SPF30	Everyday Group Limted	2d42034a-4ada-57cf-e063-6394a90a0b5f	2025-12-04	Warnings	Exact identifier application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen	SUNSCREEN 30 MINERAL	LE COSMETICS INC	3bb54b93-0ab2-2ecc-e063-6394a90acac3	2025-12-04	Warnings	Exact identifier application number: M020
Good Times SPF 50 Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	EVERYDAY GROUP LIMITED	f40c6c4a-47a2-5dfe-e053-2995a90a3df3	2025-12-04	Warnings	Exact identifier application number: M020
Sheer Guard Natural Mineral Sunscreen	ZINC OXIDE	EVERYDAY GROUP LIMITED	3257719d-dcc6-7ac5-e063-6294a90aafcd	2025-12-04	Warnings	Exact identifier application number: M020
Sun Glazed SPF 30 Sunscreen Glow Oil	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	EVERYDAY GROUP LIMITED	dba8075b-be36-4787-b23d-942d0e792aa8	2025-12-04	Warnings	Exact identifier application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 Deep	ZINC OXIDE	Crunchi, LLC.	0dc478e0-9555-4ce6-b448-7d58e3a6bae0	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Shield SPF40	SOLBAR SHIELD SPF40	Person and Covey	bd3a9a94-fc87-4127-abf9-29e56ac9ce5d	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Thirty SPF 30	SOLBAR THIRTY SPF30	Person and Covey	ab9ac056-61d9-43d5-a3db-2d487897cc69	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Fifty SPF50	SOLBAR FIFTY SPF50	Person and Covey	41fd3844-181c-4cb2-8379-f313104351ef	2025-12-04	Warnings	Exact identifier application number: M020
Solbar Avo SPF35	SOLBAR AVO SPF35	Person and Covey	bfe1e828-76d4-4db3-a8ba-b54b31baacad	2025-12-04	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