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		2026-10-16
excluded package	package	82038-004	82038-004-02	I	Inactivated by FDA		2026-10-16

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 74 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	6edc0941-bb21-4797-a875-81f727694774	2026-01-19	Warnings	Exact identifier application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)	ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%	Grace and Fire USA Inc.	48c1b93c-9c6f-95aa-e063-6294a90a0cfa	2026-01-19	Warnings	Exact identifier application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	446ac344-1078-4cd1-e063-6294a90a4bd4	2026-01-19	Warnings	Exact identifier application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	31af7b5e-2bd6-63ee-e063-6294a90a0806	2026-01-19	Warnings	Exact identifier application number: M020
ANUA INVISIBLE MATTE FINISH SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Founders Inc.	4248deaf-ad55-a9b4-e063-6294a90a55cc	2026-01-19	Warnings	Exact identifier application number: M020
ONSART Mineral Sunscreen	ZINC OXIDE 24%	Guangzhou Huixue Biotechnology Co., Ltd.	48c9d08d-9a91-7df5-e063-6294a90a1c4a	2026-01-19	Warnings	Exact identifier application number: M020
Intense Moisture Day Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	CVS Health	795d3546-f0dd-4b54-9807-9cdb3e626181	2026-01-19	Warnings	Exact identifier application number: M020
CURESHIELD MANICURE SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	48b4fad7-073d-d983-e063-6394a90ae314	2026-01-18	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	65ff0448-17e6-42ce-989a-940794fcbd8c	2026-01-17	Warnings	Exact identifier application number: M020
BenzoAzeline 10	BENZOYL PEROXIDE	Noon Aesthetics M.R. Ltd	985efa19-bd91-45cd-a2a0-d71ec325e51c	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Berry SPF 30	PREQUEL LIP VISOR BERRY SPF 30	The Center Brands, LLC	e4f3a0eb-4a8c-4145-92e4-979f03e3a511	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Blush SPF 30	PREQUEL LIP VISOR BLUSH SPF 30	The Center Brands, LLC	bc681245-e158-4cfa-9718-7ec4cff0e60d	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Mahogany SPF 30	PREQUEL LIP VISOR MAHOGANY SPF 30	The Center Brands, LLC	ea8dcd14-3c54-46a6-aabc-3655f051065b	2026-01-16	Warnings	Exact identifier application number: M020
Prequel Lip Visor Nude SPF 30	PREQUEL LIP VISOR NUDE SPF 30	The Center Brands, LLC	03a7c77d-7b6e-4720-88f1-492ce57c7145	2026-01-16	Warnings	Exact identifier application number: M020
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30	ZINC OXIDE	CVL Cosmetics North America Inc	f3057856-1461-41d3-a5c4-9f12e3a4a0ee	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	04e9c4d8-1600-4ffc-8578-4ffb82b106f3	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1aae19da-1e73-41ed-91dc-0746ad311b87	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	22d4452d-3798-48c6-a7a4-4af0f99b4ebd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d6800bb7-16ef-48f6-a09a-0422e64ad8bd	2026-01-16	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