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		2026-10-30
excluded package	package	82038-003	82038-003-02	I	Inactivated by FDA		2026-10-30

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 226 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sum 37 Micro Active Daily Moisture Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2eea94e1-2409-8ad6-e063-6294a90a5df8	2025-03-03	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21c9f9-acf8-997b-e063-6394a90ada3f	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e232e8d-4274-68bc-e063-6394a90a942b	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e23d463-fbc1-5718-e063-6294a90a7272	2025-03-01	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Deep)	ZINC OXIDE	Eminence Organic Skin Care	2e24391f-4982-efae-e063-6394a90accaa	2025-03-01	Warnings	Exact identifier application number: M020
FRUDIA Blueberry Hydrating Air Fit Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	WELCOS CO.,LTD.	8b2a1baa-e528-48d6-9cd8-c3cb55e0641b	2025-02-28	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f1b5454-8bf5-b447-e063-6394a90a743a	2025-02-27	Warnings	Exact identifier application number: M020
Clear Defense SPF 45	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	d681d92f-3501-4fca-b629-096341f20ab1	2025-02-27	Warnings	Exact identifier application number: M020
HA Physical Tint SPF 44	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a5e19d77-703e-41e0-9a02-19227dc6c819	2025-02-27	Warnings	Exact identifier application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Private Label Skin Care	18444581-66a4-4eda-a8df-627fa3b4b98a	2025-02-26	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL	ZINC OXIDE/TITANIUM DIOXIDE	SPF Ventures, LLC	2f069114-9ca8-aed4-e063-6394a90a46d8	2025-02-26	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Cream	230 N	Melaleuca Inc.	2f133abb-cad2-2ac8-e063-6294a90aa480	2025-02-26	Warnings	Exact identifier application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERAL	ZINC OXIDE	SPF Ventures, LLC	2f17b5fe-44da-964b-e063-6394a90ae699	2025-02-26	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2efb73a6-601d-61a4-e063-6294a90af825	2025-02-25	Warnings	Exact identifier application number: M020
Rida Hair Research Institute	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Rida LLC	ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 70 Peach Blossom	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed217698-f552-677e-e053-2995a90acb0a	2025-02-25	Warnings	Exact identifier application number: M020
COOLA Classic Body SPF 30 Tropical Coconut	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed0f8249-aba8-b67c-e053-2a95a90af7eb	2025-02-25	Warnings	Exact identifier application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	f176c1b1-f539-417f-98b5-69d99365f2f2	2025-02-25	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Tan)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2ee82379-6609-fd8e-e063-6294a90acf6c	2025-02-24	Warnings	Exact identifier application number: M020
Vacation SPF 50 Classic	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vacation Inc.	f2780cb5-063c-10d3-e053-2995a90a8576	2025-02-24	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