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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
H.E.B Solutions Sunscreen	COCONUT PINEAPPLE SCENTED SPF 50 STICK	H.E.B	29aef42c-f617-4c56-a166-8e1f0d6dbfd0	2021-07-09	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	58465981-e84c-4eaf-b7d5-fad1666f63fc	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	b2259b27-e1a5-482c-8916-356c1ee9774a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	FACE SPF 70 LOTION	H.E.B	73b49068-953b-496d-8ea9-404df7e79089	2021-01-19	Warnings	Exact identifier application number: M020
Think Every Day Face Sunscreen SPF 30	ZINC OXIDE	thinkOperations,LLC	afed91dd-8544-4b4b-e053-2995a90a2d16	2020-09-22	Warnings	Exact identifier application number: M020
THINKSPORT Kids sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d	2020-09-08	Warnings	Exact identifier application number: M020
THINKBABY Baby Sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	820317d2-1803-4949-bddf-09521a5d1750	2020-09-08	Warnings	Exact identifier application number: M020
THINKSPORT sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea	2020-08-03	Warnings	Exact identifier application number: M020
ESSENTIALS Face and Body Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3	2020-04-02	Warnings	Exact identifier application number: M020
Thinksport Sunscreen SPF 18	ZINC OXIDE	thinkOperations,LLC	9cd5010c-0b23-2888-e053-2995a90adb72	2020-01-23	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