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 103 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	LABORATOIRES DERMO-COSMETIK INC.	468c90d7-3b9e-1641-e063-6394a90a928c	2025-12-22	Warnings	Exact identifier application number: M020
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	468d6476-127a-e9f0-e063-6294a90a3df9	2025-12-22	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3e65ec1a-0ed9-433d-8da9-a6cb61829911	2025-12-22	Warnings	Exact identifier application number: M020
Sun Shades Sunscreen Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Melaleuca Inc.	1f982f03-9542-29f9-e063-6294a90a959c	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	ca99b8c4-6778-43dc-bdd5-ca4a470860a0	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	f810843b-5a4d-6cbc-e053-6294a90ac9e3	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	7a5644b9-4368-4e9a-aa22-b3307acf43cc	2025-12-22	Warnings	Exact identifier application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30	ZINC OXIDE	SOLARA SUNCARE, INC.	cbf9c715-2d45-4c1b-b58f-42795722821c	2025-12-22	Warnings	Exact identifier application number: M020
SPF 50 Baby Sunscreen Equate	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Walmart Inc	4690d89b-ae61-2ed5-e063-6294a90a743f	2025-12-22	Warnings	Exact identifier application number: M020
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50	ZINC OXIDE	SOLARA SUNCARE, INC.	f5242c7d-09e1-4141-8de1-a89bd7981ca6	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc9	2025-12-22	Warnings	Exact identifier application number: M020
Go Daily Defense Soothing Mineral Face Sunscreen SPF-30	ZINC OXIDE	SOLARA SUNCARE, INC.	fd040893-b1e5-783f-e053-6294a90ac216	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95	2025-12-22	Warnings	Exact identifier application number: M020
GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50	ZINC OXIDE	SOLARA SUNCARE, INC.	f3bb46e8-a9a5-b184-e053-2995a90afca7	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - POUT PROTECTOR SPF-15	ZINC OXIDE	SOLARA SUNCARE, INC.	ab6a326d-3b93-4122-a9f2-05e8203d31ef	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - FORTUNE TELLER SPF-30	ZINC OXIDE	SOLARA SUNCARE, INC.	f434de33-5da8-57ef-e053-2a95a90a8502	2025-12-22	Warnings	Exact identifier application number: M020
SPF 50 Kids Sunscreen Equate	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Walmart Inc	46919f43-2dee-57b1-e063-6294a90a15eb	2025-12-22	Warnings	Exact identifier application number: M020
SPF 30 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walmart Inc	46919f45-e3f3-4ed0-e063-6294a90a9835	2025-12-22	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	451bb734-d54d-e24e-e063-6394a90a1adb	2025-12-21	Warnings	Exact identifier application number: M020
CabanaClear Illuminating SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	NAKED SUNDAYS PTY LTD	47d1a39e-f645-c33d-e063-6394a90ad1ef	2025-12-21	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