Protectif untinted

Product NDC: 82038-004
11-digit product format: 820380004
Labeler code: 82038
Product ID: 82038-004_e273cc47-7609-7f72-e053-2a95a90acdc5
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	82038-004		I	Inactivated by FDA		2026-10-15
excluded package	package	82038-004	82038-004-02	I	Inactivated by FDA		2026-10-15

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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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	82038-004-02	`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
82038-004-02	2024-01-30	C162847	48780-1	1030e365-3eb8-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82038-004-01	Protectif untinted	100 g in 1 TUBE	CREAM	100		1
82038-004-02	Protectif untinted	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
82038-004	PROTECTIF UNTINTED (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Legacy NDC, 2 package rows	20220629_e273ccfc-3b2e-fdf4-e053-2a95a90ae4a3.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 44 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRUST MD SPF30 STEM CELL FACE	OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE	Guangzhou Yapheon Health Industry Co., Ltd.	4f2ca12c-bc6f-61b8-e063-6294a90a0d7e	2026-04-11	Warnings	Exact identifier application number: M020
MIDHA Rice Daily Moisture Sun Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MIDHA Cosmetic Co.,Ltd.	4b394107-7830-c2c6-e063-6294a90a07d9	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Deep	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f15d5ba-6396-56bf-e063-6394a90adb06	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Light	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f165895-aa84-e215-e063-6394a90a6256	2026-04-10	Warnings	Exact identifier application number: M020
Abib Dewy tinted sunscreen Glow tube Medium	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	FOURCOMPANY CO., LTD.	4f16b8a4-4279-5f79-e063-6294a90a353d	2026-04-10	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	f5ca0416-548c-4be0-a69e-c7e1b52aba95	2026-04-10	Warnings, Adverse reactions	Exact identifier application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT	ZINC OXIDE	The Green Cricket Inc	c56fd135-f46a-51ce-e053-2a95a90ab7b3	2026-04-10	Warnings	Exact identifier application number: M020
CorTex SunX 50 Thick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CoreTex Products Inc	f67a6c6c-c314-1c9d-e053-2a95a90a7f1a	2026-04-10	Warnings	Exact identifier application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18	OCTINOXATE AND ZINC OXIDE	NSE Products, Inc.	b9635e59-bb08-4167-b7ba-54c3fc712589	2026-04-09	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	79c6fe2a-34c2-44cc-81bc-796c4463d2a6	2026-04-09	Warnings, Adverse reactions	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdbae5-84ec-7b1d-e063-6294a90a2878	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15	SUNSCREEN LIP BALM	Arizona Sun Products	11e9cb25-6ff8-a121-e063-6394a90a849e	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 8	SUNSCREEN	Arizona Sun Products	11e8b612-29be-47ed-e063-6394a90ab9e7	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fdcfd0-8b24-7efc-e063-6294a90af7fa	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Cycleblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e71a84-12d1-2d4f-e063-6294a90adcd6	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Bikerblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e6eafd-f967-b748-e063-6394a90aabfd	2026-04-09	Warnings	Exact identifier application number: M020
YSE Beauty Skin Glow Primer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MSS Beauty LLC	6a318e27-14e5-488e-ac19-010f69cb743d	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30	SUNSCREEN	Arizona Sun Products	116ed17c-3b38-5e96-e063-6294a90a4246	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun SPF 45 Surfblok Sunscreen	SUNSCREEN	Arizona Sun Products	11e76815-9316-555d-e063-6294a90aeb81	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Moisturizer SPF 3	MOISTURIZER	Arizona Sun Products	1171af26-3040-552c-e063-6294a90ae220	2026-04-09	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	Marketing end	Sample	Exclude flag	Status
82038-004-01	82038000401	100 g in 1 TUBE	100 g					Historical
82038-004-02	82038000402	1 TUBE in 1 CARTON (82038-004-02) > 100 g in 1 TUBE (82038-004-01)	1 tube	2022-06-22	0000-00-00	No	No	Current