HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted

Product NDC: 81679-203
11-digit product format: 816790203
Labeler code: 81679
Product ID: 81679-203_296f0692-e2e0-4e97-872f-9ae03bebca27
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Hutton, Kathleen MD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-02-17
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 80; 38 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	81679-203		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81679-203	81679-203-50	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	80 mg/g
ZINC OXIDE	38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
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
293a6a6c-adf3-452d-92f5-3baceb619e39	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81679-203-50	HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted	53 g in 1 BOTTLE, PUMP	CREAM	53		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81679-203	HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD]	2	Current NDC, 1 package rows	20250119_293a6a6c-adf3-452d-92f5-3baceb619e39.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 144 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-Tinted Foaming Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	3698c076-68b1-7d28-e063-6394a90a517c	2025-12-09		Exact identifier application number: M020
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	THE AESTHETICS ACADEMY, LLC	3699159a-3561-9ff6-e063-6394a90af9fd	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c1723-fb1d-ae3c-e063-6294a90a4609	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	3249d05b-0f5c-4787-e063-6294a90aa0d7	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c3a18-ba8f-912d-e063-6394a90a2447	2025-12-09		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325c8641-1161-b8ac-e063-6394a90ae451	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Silk Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	3248eb22-1e10-2091-e063-6394a90ad3e1	2025-12-09		Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rhonda J Pomerantz MD PLLC	325cce54-a885-d586-e063-6394a90a90db	2025-12-09		Exact identifier application number: M020
Sheer Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRU SKIN RITUALS	324acd75-9c38-4adc-e063-6394a90afa12	2025-12-09		Exact identifier application number: M020
Sheer Mineral Sunscreen Satin Dewy Finish	ZINC OXIDE	TRU SKIN RITUALS	324960e6-c1e7-d2b9-e063-6294a90a92ce	2025-12-09		Exact identifier application number: M020
Sol Purpose Mineral Sunscreen Tinted	ZINC OXIDE	TRU SKIN RITUALS	324a3475-07f0-033c-e063-6394a90a811a	2025-12-09		Exact identifier application number: M020
Perfect Sunscreen SPF 50 Sheer Mineral	ZINC OXIDE	Bluemercury, Inc.	d8f483ff-b990-40c5-b5b8-00065051ae7e	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Non-Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42674013-fa2b-42d7-e063-6294a90af999	2025-12-09	Warnings	Exact identifier application number: M020
Hydraboost Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Bluemercury	eca867e6-4deb-4be2-ae3f-6850fb6223b3	2025-12-09	Warnings	Exact identifier application number: M020
Foto Facial Age Delay Matte Tinted	TITANIUM DIOXIDE ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42761919-8ae2-3c41-e063-6394a90abb8f	2025-12-09	Warnings	Exact identifier application number: M020
Dew Mineral	ZINC OXIDE	ADVANCED AESTHETIC DERMATOLOGY	42f17245-92a9-3915-e063-6394a90a6817	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69b707-07ff-1a82-e063-6394a90a9fcd	2025-12-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c69f93f-0385-365c-e063-6394a90a12fd	2025-12-09	Warnings	Exact identifier application number: M020
Replenishing Daily Protection Tinted	ZINC OXIDE	YUMA ACNE CLINIC, L.L.C.	3c6a5601-a7a2-5e20-e063-6394a90a6643	2025-12-09	Warnings	Exact identifier application number: M020
Bronzing Blendrops Broad Spectrum SPF 40	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	124ca946-8412-4d6d-e063-6294a90a6338	2025-12-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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	Sample	Exclude flag	Status
81679-203-50	81679020350	53 g in 1 BOTTLE, PUMP (81679-203-50)	53 g	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Hutton, Kathleen MD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2025-01-16	HUMAN OTC DRUG LABEL	2