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 63 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Moisture	HOMOSALATE, ZINC OXIDE	Walmart Inc.	b45d0ab6-b14d-4e3e-807a-886e6fffdded	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M020
Ganrek SUNSCREEN SPRAYER Broad Spectrum SPF 50	SUNSCREEN SPF 50	Guangzhou Meixi Biotechnology Co., Ltd.	4a3adb04-5e3a-80bf-e063-6294a90a6047	2026-02-10	Warnings	Exact identifier application number: M020
Sugargirl Glow Up Body Illuminator Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	364d4d87-2d3e-4515-a3f2-1506d871699d	2026-02-10	Warnings	Exact identifier application number: M020
Sugargirl Sunshine Body Illuminator Glowy Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ea801e6c-44f9-4ec9-9022-5b637baf7d59	2026-02-10	Warnings	Exact identifier application number: M020
Poolside Golden Hour SPF 15 Sunscreen Lip	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	7d0f8319-f0fa-4ea7-bb66-427c5a78145a	2026-02-10	Warnings	Exact identifier application number: M020
Tanri Broad Spectrum SPF 30	SUNSCREEN	I. Shay Cosmetics	26d5b9d1-d669-3430-e063-6394a90ad7f2	2026-02-10	Warnings	Exact identifier application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30	ZINC OXIDE	S+	9d6ffe56-debc-4ad2-837b-fd7bb091a56f	2026-02-09	Warnings	Exact identifier application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a9c970c8-b6e3-b0a1-e053-2a95a90a89c7	2026-02-09	Warnings	Exact identifier application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face	ZINC OXIDE	Solavida, LLC	4a694cdf-496b-3bc0-e063-6294a90af0d1	2026-02-09	Warnings	Exact identifier application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BENOW BEAUTY INC	32bfb17c-5535-c016-e063-6394a90a1814	2026-02-09	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	4a6b69ed-2739-d22a-e063-6294a90a1e52	2026-02-09	Warnings	Exact identifier application number: M020
SUNPLUS LIP LIFE	SUNSCREEN	I. Shay Cosmetics	26d28286-e812-0fb3-e063-6394a90a338d	2026-02-09	Warnings	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	bb86322d-ff30-4a54-97b5-1be275067146	2026-02-06	Warnings	Exact identifier application number: M020
Hampton Sun SPF 50 Mineral	ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	d6c33436-042e-44e8-8b55-98be6e246879	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER	OCTINOXATE, TITANIUM DIOXIDE	Shiseido Americas Corporation	f291f077-1c72-48fc-bb19-c20bdeaaa596	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROL	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Shiseido Americas Corporation	f225a736-2ff7-4084-88a4-a8df5b043cce	2026-02-06	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	American Sales Company	79dff6ec-d958-4bba-999b-da4aa67519f5	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate, Octocrylene	SUNSCREEN	Retail Business Services, LLC	1dc325bb-d520-4897-b8f8-3f0ecba2274c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	d8a55217-ae50-4c7f-a440-f4de079d08ae	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	f2a4b432-118e-42a4-baeb-90614dccbd06	2026-02-06	Warnings, Adverse reactions	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