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 139 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b2403-4f4a-3e77-e063-6294a90a4f0a	2025-12-10		Exact identifier application number: M020
Sheer Mineral Sunscreen Bar	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342b69d5-f0e1-99cd-e063-6294a90abb6e	2025-12-10		Exact identifier application number: M020
Sheer Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BB MEDICAL & DERMATOLOGY INC	342c3f42-c17f-f777-e063-6394a90a8058	2025-12-10		Exact identifier application number: M020
Lip SPF	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396d3fdd-99d8-77e8-e063-6294a90aec2f	2025-12-10		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396cae82-7641-e1b2-e063-6394a90a7c07	2025-12-10		Exact identifier application number: M020
Solar Knight SPF 40 Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	MASCARENAS ENTERPRISES, INC.	36c27c91-22ac-205c-e063-6294a90ab379	2025-12-10		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	FRANCISCO FLORES, M.D., P.A.	396ce15a-06ad-4055-e063-6294a90a27fb	2025-12-10		Exact identifier application number: M020
Dermablue Daily Replenishing	ZINC OXIDE	Dermablue, P.C.	308da9c9-544e-d5d1-e063-6294a90aa49b	2025-12-10	Warnings	Exact identifier application number: M020
Recoverie Mineral Matte	ZINC OXIDE	Clear Day Acne Clinic	308f41de-fb14-40f9-e063-6394a90a008f	2025-12-10	Warnings	Exact identifier application number: M020
AL0043600 Alba Botanica VE Herbal Healing Body	COLLOIDAL OATMEAL	The Hain Celestial Group, Inc.	60672feb-141f-651e-e053-2a91aa0af41d	2025-12-10	Warnings	Exact identifier application number: M020
UV Defense me. Matte Airy-Fit Sunscreen	ZINC OXIDE	MAGNIF CO., LTD	459f2b8d-453c-4dee-e063-6394a90a4509	2025-12-10	Warnings	Exact identifier application number: M020
RoC Hydration Plus SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	45a3e250-8195-344d-e063-6294a90ae681	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	bf3c1474-e353-63a5-e053-2a95a90a9b26	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	f161d754-0c32-2fbe-e053-2a95a90a6b47	2025-12-10	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242ff053-b8c0-4f90-e063-6294a90a7bb3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ef1f8-ad12-4f80-e063-6394a90a3e3c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e810d366-0c32-5b1c-e053-2a95a90a622e	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242b7d0e-82d8-793c-e063-6294a90a4aa3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	eb744367-f318-e1e2-e053-2a95a90a2cc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242faaed-e85a-a1d7-e063-6294a90aea92	2025-12-09	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