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 161 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Soft Bisque Perfecting Makeup SPF 25 Merle Norman	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	e8b11940-6ac4-4c80-a732-2f86f2b7ebfe	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	d54a35a2-4f5d-4aec-8be4-1d8e00d4618f	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	d6be5b8e-0094-40de-91a6-bc52b3f8a987	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Creamy Beige Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	da149594-8a75-4b8d-9b6a-068231ce153b	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Pure Beige Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	95821b1c-c894-4b3f-94c2-008349730203	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Porcelain Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	cce60274-ef8a-4638-a2c8-e869fc9e2a7c	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Quiet Rose Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	776f5cb5-9d0e-4057-9600-e18b2b8a249a	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Sandy Beige Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	2406806e-f5ff-4c54-bf33-a96afaea1ccc	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Sesame Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	70b94df9-2160-450c-a722-cb842f58c319	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Simply Beige Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	7797fcb4-2080-415a-9b4b-541051838093	2025-11-19	Warnings	Exact identifier application number: M020
Timeless Illuminating Makeup SPF 30 Soft Bisque Merle Norman	OCTINOXATE, OXYBENZONE	Merle Norman Cosmetics, Inc	e5a63ffc-32e6-4bb1-907a-8697791f57bf	2025-11-19	Warnings	Exact identifier application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle Norman	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	98ebaa5c-ba28-4e70-a45c-6545eb756d8f	2025-11-19	Warnings	Exact identifier application number: M020
Softlips Vanilla	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	8dff782f-7201-4ad9-94d2-672058f817b8	2025-11-19	Warnings	Exact identifier application number: M020
Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum SPF30	AVOBENZONE, OXTINOXATE, OCTOCRYLENE, OXYBENZONE	Baxter Laboratories Pty. Ltd.	43923c68-87ad-1ab7-e063-6394a90adf7a	2025-11-18	Warnings	Exact identifier application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	43e36351-4caf-3393-e063-6394a90a00b1	2025-11-18	Warnings	Exact identifier application number: M020
Perfecting Blendrops Broad Spectrum SPF 46	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	43e454cf-dac8-4c2f-e063-6394a90a7097	2025-11-18	Warnings	Exact identifier application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	H.E.B.	43e55eb7-6572-bd88-e063-6294a90aa7ee	2025-11-18	Warnings	Exact identifier application number: M020
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	ff396aca-cf64-45f8-ba2e-c4fc55d6484b	2025-11-18	Warnings	Exact identifier application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Merle Norman Cosmetics, Inc.	d10272ea-aedd-5759-e053-2a95a90a3ab3	2025-11-18	Warnings	Exact identifier application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Drmtlgy, LLC	bd0981cb-49ce-4eaf-bd9e-db48f56b7314	2025-11-18	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