Protectif fair tint

Product NDC: 82038-003
11-digit product format: 820380003
Labeler code: 82038
Product ID: 82038-003_e273a7ad-dad5-122f-e053-2a95a90a685f
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	82038-003		I	Inactivated by FDA		2026-10-23
excluded package	package	82038-003	82038-003-02	I	Inactivated by FDA		2026-10-23

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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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	82038-003-02	`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
82038-003-02	2024-01-30	C162847	48780-1	1030e365-5d12-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82038-003-01	Protectif fair tint	100 g in 1 TUBE	CREAM	100		1
82038-003-02	Protectif fair 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
82038-003	PROTECTIF FAIR TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Legacy NDC, 2 package rows	20220629_e273a835-0ef0-6228-e053-2995a90afb04.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 180 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wonderscreen Broad Spectrum SPF 30	ZINC OXIDE	Wasatch Product Development, LLC.	e895d942-e50e-1ad6-e053-2995a90a0e02	2025-10-10	Warnings	Exact identifier application number: M020
Illuminating SPF 50 plus drops Broad Spectrum Sunscreen	ZINC OXIDE	Cosmetic Enterprise Ltd	13f40485-b98e-e804-e063-6394a90af2af	2025-10-10	Warnings	Exact identifier application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Cosmetic Enterprises LTD	a84d246b-1153-85ff-e053-2995a90a270a	2025-10-10	Warnings	Exact identifier application number: M020
MediChoice Moisturizing Lip Balm SPF15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	O&M HALYARD, INC.	00327815-28f0-4198-bca7-c8ae768ff416	2025-10-09	Warnings	Exact identifier application number: M020
Daybird 4-in-1 Skin Tint Serum	ZINC OXIDE	Resette, Inc.	19c1a934-b0f5-1068-e063-6294a90a3b1f	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 604)	ZINC OXIDE	B.A.I. Biosciences INC.	f4ebbc1d-d521-1a47-e053-2a95a90a6f84	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 774)	ZINC OXIDE	B.A.I. Biosciences INC.	f4ebd850-11a8-0d43-e053-2a95a90a2d34	2025-10-09	Warnings	Exact identifier application number: M020
pavise Lip Defense tinted hydrating oil (hue 616)	ZINC OXIDE	B.A.I. Biosciences INC.	f4eb6b20-7c26-2942-e053-2a95a90abd31	2025-10-09	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4346f7a-3642-05d8-e053-2a95a90a013d	2025-10-09	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4206dad-6a17-2f56-e053-2a95a90a69dc	2025-10-09	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f434089c-126f-441c-e053-2995a90ab0c7	2025-10-09	Warnings	Exact identifier application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)	ZINC OXIDE	Napoleon PerdisCosmetic Pty Ltd	be64bb40-b1a9-2308-e053-2a95a90a69c8	2025-10-09	Warnings	Exact identifier application number: M020
Organys Open Formula Sheer	ZINC OXIDE	Organys Beauty	0b3ab551-cb66-cf86-e063-6394a90a7ab4	2025-10-09	Warnings	Exact identifier application number: M020
Dr Lift Mineral SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	40c03d65-8d09-371a-e063-6294a90a7ac6	2025-10-09	Warnings	Exact identifier application number: M020
Organys Derma Made Sheer	ZINC OXIDE	Organys Beauty	0b39f550-bd34-509d-e063-6294a90a51d0	2025-10-09	Warnings	Exact identifier application number: M020
Organys Derma Made	ZINC OXIDE	Organys Beauty	0b37a73b-73ca-501f-e063-6294a90a6291	2025-10-09	Warnings	Exact identifier application number: M020
Organys Derma Made	ZINC OXIDE	Organys Beauty	09b8b8c0-4066-9cbe-e063-6394a90aca24	2025-10-09	Warnings	Exact identifier application number: M020
Dr Lift Mineral SPF 30	TITANIUM DIOXIDE	Spa de Soleil	40c0e0d2-2c1d-e629-e063-6394a90a5aaf	2025-10-09	Warnings	Exact identifier application number: M020
Daybird Tinted Skincare (SHADE 3)	ZINC OXIDE	Resette, Inc	dc89ab76-da32-4f6f-e053-2995a90a8bcb	2025-10-09	Warnings	Exact identifier application number: M020
Daybird Tinted Skincare (SHADE 4)	ZINC OXIDE	Resette, Inc	dc89ab0b-d53e-983f-e053-2a95a90a127f	2025-10-09	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
82038-003-01	82038000301	100 g in 1 TUBE	100 g					Historical
82038-003-02	82038000302	1 TUBE in 1 CARTON (82038-003-02) > 100 g in 1 TUBE (82038-003-01)	1 tube	2022-06-22	0000-00-00	No	No	Current