Protectif deep tint

Product NDC: 82038-002
11-digit product format: 820380002
Labeler code: 82038
Product ID: 82038-002_e24b42d2-aa50-a0f9-e053-2a95a90aa1b8
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: 2022-06-21
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	82038-002		I	Inactivated by FDA		2026-10-15
excluded package	package	82038-002	82038-002-02	I	Inactivated by FDA		2026-10-15

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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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	82038-002-02	`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
82038-002-02	2024-01-30	C162847	48780-1	1030e364-fcae-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82038-002-01	Protectif deep tint	100 g in 1 TUBE	CREAM	100		1
82038-002-02	Protectif deep 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
82038-002	PROTECTIF DEEP TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Legacy NDC, 2 package rows	20220626_e24b5194-0716-4de2-e053-2a95a90adb5f.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 11 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEDICUBE PDRN SILKY SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	APR US INC	57154bec-6714-0314-e063-6294a90a4bd0	2026-07-20	Warnings	Exact identifier application number: M020
TOCOBO Double UV Defense Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON Co., Ltd.	56aff65a-aa08-dc3f-e063-6294a90acac3	2026-07-19	Warnings	Exact identifier application number: M020
THE SPORTO Invisible Sport for Body	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	46564a09-909d-bcc7-e063-6294a90a627b	2026-07-17	Warnings	Exact identifier application number: M020
RR Sun Creme	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	dc60b685-a7fc-47bb-ade9-44a8e3b54812	2026-07-17	Warnings	Exact identifier application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	0ef2ebae-7198-47f4-8891-d1ca3cf54d4b	2026-07-16	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	PMI Branded Pharmaceuticals, Inc.	f9be5adb-dce3-4b17-939f-d80d486f2cb0	2026-07-16	Warnings	Exact identifier application number: M020
BaseLife Pure Mineral Shield Sunscreen	ZINC OXIDE	Wintech America, Inc.	7f741a91-6ed8-4d08-9196-d15527d044d5	2026-07-15	Warnings	Exact identifier application number: M020
BaseLife Clear UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wintech America, Inc.	128db446-93ba-4347-bd39-66177572c659	2026-07-15	Warnings	Exact identifier application number: M020
Biore Aqua Rich Facial Mist SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	Kao USA Inc.	56a80a0d-b0b5-1098-e063-6294a90a5270	2026-07-15	Warnings	Exact identifier application number: M020
Anti Aging Lip Balm Pot SPF 15	LIP BALM	Epicuren Disocovery	4097e28a-ed11-e16a-e063-6294a90a5e9b	2026-07-14	Warnings	Exact identifier application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50	ZINC OXIDE	CALM ENTERPRISE LLC	722462d8-d2ab-44ce-9065-673ab2076269	2026-07-14	Warnings	Exact identifier application number: M020
X-Treme Cream Propolis Sunscreen SPF 45	X-TREME CREAM	Epicuren Discovery	3b29976e-eee0-b978-e063-6294a90accd6	2026-07-14	Warnings	Exact identifier application number: M020
Anti-Aging Lip Balm SPF 15	LIP BALM	Epicuren Discovery	3cbd0550-b6e5-3e86-e063-6394a90ac07f	2026-07-14	Warnings	Exact identifier application number: M020
Zinc Oxide Perfecting Sunscreen	ZINC OXIDE	Epicuren Discovery	1a0228f9-bf3f-a1fe-e063-6294a90a3fb5	2026-07-14	Warnings	Exact identifier application number: M020
Vacation Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	14b8a3cf-031c-4c52-ba81-e683e69d0f37	2026-07-14	Warnings	Exact identifier application number: M020
Mederma Scar Cream	AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE	L. Perrigo Company	bd5c9df7-8dfb-4d20-9966-e148c5667b22	2026-07-14	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	4081a4ad-b738-5fb6-e063-6394a90a9171	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc5c1d8-91f8-8ad2-e063-6294a90a9229	2026-07-13	Warnings	Exact identifier application number: M020
Olay Super Serum Body Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	5513c5e2-3baf-2f09-e063-6394a90a495a	2026-07-13	Warnings	Exact identifier application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO	AVOBENZONE, HOMOSALATE, OCTISALATE	Koco Life LLC	3cc48592-f70d-664e-e063-6294a90ac6e8	2026-07-13	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
82038-002-01	82038000201	100 g in 1 TUBE	100 g					Historical
82038-002-02	82038000202	1 TUBE in 1 CARTON (82038-002-02) > 100 g in 1 TUBE (82038-002-01)	1 tube	2022-06-21	0000-00-00	No	No	Current