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 217 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32b5a19e-86d4-5ee1-e063-6394a90a12e2	2025-04-11	Warnings	Exact identifier application number: M020
LERINN ZINCPURE SUNMILK SPF 50	ZINC OXIDE	Serrina Lin Skincare Inc	32717b49-729c-a229-e063-6394a90a18fb	2025-04-10	Warnings	Exact identifier application number: M020
Smoothing Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DANIEL BEHROOZAN MD A MEDICAL CORPORATION	327246c2-9d7a-2d34-e063-6294a90a5fb7	2025-04-10		Exact identifier application number: M020
Clarity Rx Physical Skin Defense SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	b5111012-97b9-4908-95a0-d09595f9c4d9	2025-04-10	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	13e5085f-df2b-46b2-b063-e58ce4379905	2025-04-09	Warnings	Exact identifier application number: M020
Sunstation Sport Sunscreen SPF 30	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	Sunstation USA LLC	6007c125-f28a-45e5-b8f1-490ee04b7811	2025-04-09	Warnings	Exact identifier application number: M020
Pacifica Sun Dreams Illuminating SPF Foam	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Pacifica Beauty, LLC	2e0cb105-75c3-8032-e063-6394a90ab502	2025-04-09	Warnings	Exact identifier application number: M020
belif Aqua bomb - glow sunstick SPF50	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	LG H&H CO., LTD.	284cadf1-deb9-4f3d-e063-6394a90ab122	2025-04-09	Warnings	Exact identifier application number: M020
ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK	OCTINOXATE AND OXYBENZONE	Ventura Corporation LTD	aa79b1a4-6b33-47c9-b55e-b813d9b22265	2025-04-09	Warnings	Exact identifier application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only	ZINC OXIDE	SPF Ventures, LLC	3240cbe5-bfc8-17f7-e063-6394a90a1b98	2025-04-08	Warnings	Exact identifier application number: M020
ISA KNOX UV SUN PRO 365 Sheer Mineral Face	ZINC OXIDE	LG HOUSEHOLD & HEALTH CARE LTD.	2eeac795-b74e-b3a3-e063-6294a90abf52	2025-04-08	Warnings	Exact identifier application number: M020
The Face Shop Hydro Sun Barrier 2-in-1 SPF and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	2ee9f271-b508-2304-e063-6294a90a3752	2025-04-08	Warnings	Exact identifier application number: M020
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	a43d0d4f-94de-4c4b-a17a-63a819d5d293	2025-04-07	Warnings	Exact identifier application number: M020
Gangnam Glow Sunscreen 50	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	LG HOUSEHOLD & HEALTH CARE LTD.	30cc2e35-f752-8285-e063-6294a90afbf5	2025-04-07	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	26f8dc88-2096-4fa1-81ae-ea92fe1f353d	2025-04-07	Warnings	Exact identifier application number: M020
Vacation Instant Browning	AVOBENZONE OCTISALATE OCTOCRYLENE	Vacation Inc.	13028f61-3f62-22cc-e063-6394a90a6bf1	2025-04-04	Warnings	Exact identifier application number: M020
LBri Pure n Natural SPF 30	ZINC OXIDE	L'BRI HEALTH & BEAUTY	8350791d-5cf2-4358-9f85-9384d35be9f4	2025-04-03	Warnings	Exact identifier application number: M020
SHEER MINERAL SUNSCREEN	ZINC OXIDE	Plant Devas Inc. dba evanhealy	f620ef44-f30c-4cc9-bc82-28dc4a47a8da	2025-04-02	Warnings	Exact identifier application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	0116cffa-3415-746b-e063-6394a90ab3b3	2025-04-01	Warnings	Exact identifier application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE,	NAKED SUNDAYS PTY LTD	04293280-e74a-f293-e063-6394a90a06f6	2025-04-01	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