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 35 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c981ae5e-e7e8-484b-b682-fb96d501e03b	2026-05-06	Warnings	Exact identifier application number: M020
Poth Clear Gel Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Poth LLC	1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a	2026-05-06	Warnings	Exact identifier application number: M020
FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF	FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF	Horizons Ventures LLC	5127ac89-3dff-5966-e063-6394a90a11db	2026-05-06	Warnings	Exact identifier application number: M020
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Have & Be Co., Ltd.	4a7e868d-6310-6ee4-e063-6394a90aebce	2026-05-06	Warnings	Exact identifier application number: M020
Vivaiodays Sunscreen with Turmeric	ZINC OXIDE	5SENCO INC DBA VIVAIODAYS	5129e680-f485-9c66-e063-6394a90a0e7e	2026-05-06	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Soothing Sun	OCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	THANK YOU FARMER CO., LTD	300ab1bc-9c11-c2f0-e063-6394a90aa853	2026-05-06	Warnings	Exact identifier application number: M020
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	9eb7f287-cb61-4f9d-968e-16b195dbbc9a	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier application number: M020
SPF 50 Dry Tropix with fragrance	HOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Surface Products Corp	2c95f5c0-7ff6-4eac-b2d6-49e7da7e7bec	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF30 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	9592835a-7c07-487e-a955-04fdea070809	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	65f52fc8-8ddb-4282-9bc0-92a7d0e0c0f2	2026-05-05	Warnings	Exact identifier application number: M020
Knesko Skin The Sunscreen	ZINC OXIDE	Knesko, LLC	5114dc75-a865-326e-e063-6294a90a8911	2026-05-05	Warnings	Exact identifier application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance Free	HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%	Surface Products Corp	683cb489-e4e1-44ab-9543-614d42b08edd	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier application number: M020
Surface Sun SPF 50 Mineral Sunscreen	ZINC OXIDE 24%	Surface Products Corp	6f95de43-cb71-4ddd-b438-a35ee2e14fae	2026-05-05	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Port Jervis Laboratories, Inc	5118a0a4-728b-6884-e063-6394a90a02b3	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baed7205-2e0d-c6aa-e053-2995a90a8e29	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	baee366f-c1a0-5e21-e053-2a95a90a6687	2026-05-05	Warnings	Exact identifier application number: M020
Carmex Sun and Soothe Moisturizing Lip Balm SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	fc4d2387-ce6a-4105-bab4-7d371b61f770	2026-05-05	Warnings	Exact identifier application number: M020
THANKYOU FARMER Sun Project Soothing Sun	HOMOSALATE, OCTISALATE. AVOBENZONE	THANK YOU FARMER CO., LTD	3009df84-4ca7-e170-e063-6294a90a1578	2026-05-05	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