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 120 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ESTHETICS BY RIKI LLC	387d5194-bc12-68c1-e063-6394a90ab152	2025-12-15		Exact identifier application number: M020
Tinted Mineral Sun Protectant	TITANIUM DIOXIDE, ZINC OXIDE	PANDA PAMPERING LLC	387c23c2-a9f0-f484-e063-6394a90a4104	2025-12-15		Exact identifier application number: M020
Tinted Mineral Sun Protectant	TITANIUM DIOXIDE, ZINC OXIDE	PANDA PAMPERING LLC	387be96f-8cda-ce02-e063-6394a90abea5	2025-12-15		Exact identifier application number: M020
Serum Lightly Tinted	ZINC OXIDE	PANDA PAMPERING LLC	387c593b-c65b-62b5-e063-6294a90ac4c2	2025-12-15		Exact identifier application number: M020
Serum Lightly Tinted	ZINC OXIDE	PANDA PAMPERING LLC	387c9167-638c-1e30-e063-6394a90a9374	2025-12-15		Exact identifier application number: M020
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37ede476-43b6-a7c8-e063-6294a90a3e8f	2025-12-15		Exact identifier application number: M020
REJUVN8	TITANIUM DIOXIDE, ZINC OXIDE	FLEUR DE VIE LLC	37efa5e1-e88e-d251-e063-6394a90a9371	2025-12-15		Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd330bf-92e4-3664-e063-6294a90a0475	2025-12-15	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd37dd1-fd43-7af4-e063-6394a90ae3a0	2025-12-15	Warnings	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd3dcab-e9fb-0ef5-e063-6394a90acef1	2025-12-15	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	THE BEAUTY ROOM OC INC	3dd40a6a-d52e-ab87-e063-6294a90a966e	2025-12-15	Warnings	Exact identifier application number: M020
20 Zinc Oxide Non-Tinted Mineral Sunscreen	ZINC OXIDE	AGELESS SKINCARE INC	3766e6c0-8976-509d-e063-6394a90af00f	2025-12-15		Exact identifier application number: M020
20 Zinc Oxide Tinted Mineral Sunscreen	ZINC OXIDE	AGELESS SKINCARE INC	3766b00f-ceda-a6f9-e063-6294a90aff5d	2025-12-15		Exact identifier application number: M020
Mattifying Skin Primer	TITANIUM DIOXIDE, ZINC OXIDE	SKIN MAVEN	37662032-2842-1982-e063-6294a90a49a0	2025-12-15		Exact identifier application number: M020
Moisturizing Face and Body SPF	ZINC OXIDE	SKIN MAVEN	376645ee-7ea8-e738-e063-6394a90a119b	2025-12-15		Exact identifier application number: M020
Mermaid Glow And Go Non Tinted Mineral Sunscreen	ZINC OXIDE	Mermaid Glow LLC	3985a298-fe0b-c296-e063-6294a90ab6c0	2025-12-15		Exact identifier application number: M020
Mermaid Glow And Go Non Tinted Mineral Sunscreen	ZINC OXIDE	Mermaid Glow LLC	39856675-c110-a7a7-e063-6294a90ac6af	2025-12-15		Exact identifier application number: M020
Bio H Plus Daily Defense And Revitalize	ZINC OXIDE	BIOHEALTH PLUS LLC	3764f723-cc7a-2128-e063-6294a90ac894	2025-12-15		Exact identifier application number: M020
Extreme Protection Non Tinted	ZINC OXIDE	BIOHEALTH PLUS LLC	37656077-5185-817a-e063-6394a90adf5a	2025-12-15		Exact identifier application number: M020
Deluxe Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	37657895-5fec-82d0-e063-6294a90acf67	2025-12-15		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