Protectif fair tint

Product NDC: 82038-003
11-digit product format: 820380003
Labeler code: 82038
Product ID: 82038-003_e273a7ad-dad5-122f-e053-2a95a90a685f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide and Titanium dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Derma Research Group Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-06-22
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 7 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82038-003		I	Inactivated by FDA		2026-10-28
excluded package	package	82038-003	82038-003-02	I	Inactivated by FDA		2026-10-28

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82038-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82038-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82038-003-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82038-003-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82038-003-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82038-003-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82038-003-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82038-003-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82038-003-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82038-003-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82038-003-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82038-003-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82038-003-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82038-003-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82038-003-02	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82038-003-02	2024-01-30	C162847	48780-1	1030e365-5d12-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82038-003-01	Protectif fair tint	100 g in 1 TUBE	CREAM	100		1
82038-003-02	Protectif fair tint	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82038-003	PROTECTIF FAIR TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Legacy NDC, 2 package rows	20220629_e273a835-0ef0-6228-e053-2995a90afb04.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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TALLOW SUNSCREEN	NON-NANO ZINC OXIDE	FOUNDATION COMMERCE INC	363e38bf-b4b4-dcc4-e063-6294a90a5d2f	2025-05-28	Warnings	Exact identifier application number: M020
CoreTex SunX 50 Facestick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	364989ea-c93b-d404-e063-6294a90abd09	2025-05-28	Warnings	Exact identifier application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30	OCTINOXATE, ZINC OXIDE	SOLVADERM LLC	86dbd8c3-e95a-49a8-afe6-ff9d985e28ba	2025-05-27	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350b4cce-1627-5b8f-e063-6294a90aa6bf	2025-05-26	Warnings	Exact identifier application number: M020
Protect Daily Ritual Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35ce8307-387b-2b40-e063-6294a90a28bc	2025-05-23		Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	ONESKIN INC.	35d57d3f-376c-2307-e063-6294a90adf51	2025-05-23	Warnings	Exact identifier application number: M020
Oathology Inzincable Lip Balm SPF 35	ZINC OXIDE	SKINOATH LLC	289a5492-af57-42e5-82af-3f1e4b369d68	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Light	ZINC OXIDE	ALLI LLC	3cb4459b-1776-414a-b5c4-0ffb9f1df766	2025-05-22	Warnings	Exact identifier application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, Dark	ZINC OXIDE	ALLI LLC	81633684-f9ac-45cb-8a3e-f0c30b229a82	2025-05-22	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Melinda Menezes, M.D., Inc.	35bea4f3-c19e-3e2e-e063-6394a90aeb69	2025-05-22		Exact identifier application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	35c106b6-9a80-01e3-e063-6294a90abc35	2025-05-22	Warnings	Exact identifier application number: M020
COSRX	AIRY-LIGHT CLEAR SUNCREEN STICK	COSRX inc.	313b1a73-8863-c458-e063-6394a90a01d6	2025-05-20	Warnings	Exact identifier application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	MELAN INC.	f627b17f-d2dc-47bd-b865-08995995e861	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	63e078a3-d5df-4458-a745-e306d734e6be	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	90531e8f-15c6-49ac-96a4-3bdfab2bfd9b	2025-05-20	Warnings	Exact identifier application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	28db9f44-780f-4cd5-940e-3ee779f38247	2025-05-20	Warnings	Exact identifier application number: M020
Mineral Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595149d-0735-6bea-e063-6394a90a618a	2025-05-20		Exact identifier application number: M020
Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3595735e-c25f-eb48-e063-6294a90aac0f	2025-05-20		Exact identifier application number: M020
Coola Clear California Summers	OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE	COOLA, LLC	358009c4-492d-ac03-e063-6294a90af227	2025-05-19	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	ONESKIN INC.	3581f578-e19e-9ace-e063-6294a90acc34	2025-05-19	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	Marketing end	Sample	Exclude flag	Status
82038-003-01	82038000301	100 g in 1 TUBE	100 g					Historical
82038-003-02	82038000302	1 TUBE in 1 CARTON (82038-003-02) > 100 g in 1 TUBE (82038-003-01)	1 tube	2022-06-22	0000-00-00	No	No	Current