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		2026-10-16
excluded package	package	82038-003	82038-003-02	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	82038-003-02	`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 56 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunscreen SPF 50	SUNSCREEN SPF 50	Guangzhou Ariel Biotech Co., Ltd.	14b9ec0e-6fff-44b1-e063-6394a90aab97	2026-03-05	Warnings	Exact identifier application number: M020
belif Aqua bomb - glow sunstick SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	4c35fbbc-a79d-318f-e063-6394a90a30a7	2026-03-04	Warnings	Exact identifier application number: M020
Kids Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4c37855b-08c0-0aa7-e063-6394a90a8842	2026-03-04	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	be03b588-afbd-41d1-be96-444d735c9768	2026-03-03	Warnings	Exact identifier application number: M020
UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREEN	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID	Shenzhen Jufeng Qiyuan Trading Co., Ltd.	4c1a3345-58c1-93c8-e063-6394a90a865e	2026-03-03	Warnings	Exact identifier application number: M020
Botnia Gentle Sun SPF 30	ZINC OXIDE	Botnia, Inc	005d0245-fe53-47e5-888b-683f58cd6d26	2026-03-03	Warnings	Exact identifier application number: M020
Broad Spectrum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	64534ec3-396c-4c11-9ec1-e2615f7e24b1	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	9b7249e4-4c1f-40e7-a657-d40c53d9317f	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	SUNSCREEN	Old East Main Co.	1673b8b1-08ad-40a5-8180-93333a8edb67	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate	AVOBENZONE, HOMOSALATE, OCTISALATE	Old East Main Co.	32036e41-2414-4498-8e1c-61511abf7a32	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 100	AVOBENZONE HOMOSALATE OCTISALATE	Old East Main Co.	42266fa5-5f30-2a9f-e063-6394a90a1dfe	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Amazon.com Services LLC	d4b4ebac-c6c2-474b-afc6-b80b8431e90f	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M020
Fruit Snack SPF 15 Broad Spectrum Lip Balm	FRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	24c2a9fc-892b-c74d-e063-6394a90af62c	2026-03-03	Warnings	Exact identifier application number: M020
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	4c231aa1-75eb-c171-e063-6294a90a8b8b	2026-03-03	Warnings	Exact identifier application number: M020
SPF 30 Mineral Sunscreen	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4c25b4ec-b045-7066-e063-6294a90ab801	2026-03-03	Warnings	Exact identifier application number: M020
Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced Coffee	ZINC OXIDE	Good Weather Inc.	4c261e88-7f37-2361-e063-6294a90aa602	2026-03-03	Warnings	Exact identifier application number: M020
Good Weather Skin All Over Sun Milk Face and Body SPF 50	ZINC OXIDE	Good Weather Inc.	4c278acc-7cd5-0d85-e063-6394a90a3a72	2026-03-03	Warnings	Exact identifier application number: M020
Lekura - ZincDaily Natural Face Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	4c2bed23-f77b-2c97-e063-6394a90a4ca5	2026-03-03	Warnings	Exact identifier application number: M020
NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	OUTIN FUTURES CO.,LTD.	4ddce1f0-44a3-7e0c-e063-6294a90a3f7d	2026-03-03	Warnings	Exact identifier application number: M020
Bephor Reviving Suncream SPF50	ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDE	Gyeongbuk Institute of IT Convergence Industry Technology	4c055b22-94e9-ff0d-e063-6394a90ab2ec	2026-03-02	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