Protectif deep tint

Product NDC: 82038-002
11-digit product format: 820380002
Labeler code: 82038
Product ID: 82038-002_e24b42d2-aa50-a0f9-e053-2a95a90aa1b8
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: 2022-06-21
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	82038-002		I	Inactivated by FDA		2026-10-21
excluded package	package	82038-002	82038-002-02	I	Inactivated by FDA		2026-10-21

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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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
82038-002-02	2024-01-30	C162847	48780-1	1030e364-fcae-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82038-002-01	Protectif deep tint	100 g in 1 TUBE	CREAM	100		1
82038-002-02	Protectif deep 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
82038-002	PROTECTIF DEEP TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Legacy NDC, 2 package rows	20220626_e24b5194-0716-4de2-e053-2a95a90adb5f.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 112 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Tinted Mineral Sunscreen	ZINC OXIDE	Natur LLC	365f3c48-15a6-2d32-e063-6394a90aad78	2025-12-16	Exact identifier application number: M020
Non Tinted Mineral Sunscreen	ZINC OXIDE	Natur LLC	365fffa2-b846-7dd3-e063-6394a90a47cb	2025-12-16	Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	Natur LLC	36603550-9c3d-5e33-e063-6394a90adfc9	2025-12-16	Exact identifier application number: M020
Shield And Protect Tinted	ZINC OXIDE	TRILOGY LABORATORIES, LLC	37f00e51-1123-c04c-e063-6294a90abed8	2025-12-16	Exact identifier application number: M020
Shield And Protect	ZINC OXIDE	TRILOGY LABORATORIES, LLC	37f09dd5-084f-3c80-e063-6394a90a7a53	2025-12-16	Exact identifier application number: M020
Non Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766496f-231c-f98c-e063-6294a90aae08	2025-12-16	Exact identifier application number: M020
Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766b0d8-20e6-a227-e063-6294a90af4da	2025-12-16	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	ZINC OXIDE	WECARE FRISCO PLLC	37515807-e29a-3916-e063-6394a90a1ffd	2025-12-16	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	374f866d-eb52-61e3-e063-6394a90a77c7	2025-12-16	Exact identifier application number: M020
Tinted Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	3750c23d-c3f8-fac3-e063-6394a90a135e	2025-12-16	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40	ZINC OXIDE	WECARE FRISCO PLLC	374fe86e-cbe8-f911-e063-6294a90a9600	2025-12-16	Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	WECARE FRISCO PLLC	37507b14-fc01-5e27-e063-6294a90afd50	2025-12-16	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	ZINC OXIDE	WECARE FRISCO PLLC	375203a6-2ab8-2a80-e063-6294a90ada72	2025-12-16	Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	WECARE FRISCO PLLC	3751caa3-867e-5901-e063-6294a90ab6bd	2025-12-16	Exact identifier application number: M020
Auset Tinted Replenishing Daily Protection	ZINC OXIDE	SHAYLA BOGER SKIN THERAPY LLC	37da48d6-8f12-ec97-e063-6294a90a699c	2025-12-16	Exact identifier application number: M020
Morning Replenish	ZINC OXIDE	KATHY JONES AESTHETHICS LLC	37da711e-840b-2f2a-e063-6294a90ab16c	2025-12-16	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	KATHY JONES AESTHETHICS LLC	37dab729-5988-5eba-e063-6294a90ac6b7	2025-12-16	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tory Sullivan, M.D., P.A.	36241e60-f02a-50a7-e063-6394a90a6390	2025-12-16	Exact identifier application number: M020
Ageless All Fitz	ZINC OXIDE	A.Wall Beauty LLC	37670cb1-ac75-5049-e063-6394a90a4d0a	2025-12-16	Exact identifier application number: M020
Tinted Replenishing Daily Protection	ZINC OXIDE	Tory Sullivan, M.D., P.A.	36244b27-20e5-f370-e063-6294a90a1f6c	2025-12-16	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
82038-002-01	82038000201	100 g in 1 TUBE	100 g					Historical
82038-002-02	82038000202	1 TUBE in 1 CARTON (82038-002-02) > 100 g in 1 TUBE (82038-002-01)	1 tube	2022-06-21	0000-00-00	No	No	Current