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		2026-10-28
excluded package	package	82038-002	82038-002-02	I	Inactivated by FDA		2026-10-28

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 198 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37f01f66-c604-4fc3-a263-2089db91283f	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	bca57893-bd2d-44ac-a503-2f11c3b62bf2	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37188b77-ab0b-4bea-b839-99e589600a2b	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c89e45d6-2322-4913-a557-e1780a86fd63	2025-08-11	Warnings	Exact identifier application number: M020
Sun Bum Face 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1ed89c-6d50-6400-e063-6294a90a1433	2025-08-11	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	24e9ea4d-3073-c126-e063-6394a90a7c6e	2025-08-10	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	d1c5b7a5-73f9-4df6-9469-ce42e4f33ae8	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	96efeb92-a276-4ac9-b30a-11b4fa367263	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER PEACH SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	edeb2ee1-cc84-4254-80c1-6410cd77c422	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER STRAWBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	7abe936b-a4d5-457c-9cdd-761b201bb046	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER BLUEBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	e4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	8be1c27c-7988-47c4-b613-3bc86f53981e	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRY	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	a3c8d778-ce9c-46eb-a0c3-6886eb1d3934	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	6cdb0b61-a9c2-4a78-9752-8e7aedaeef45	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINK	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	f1b6c068-06d2-4a44-8199-7111d1b6a0d6	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER COOKIE SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	0274f5f1-1ee1-48a5-af7a-deb3aa3a34d7	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER ICE MINT SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	a355777b-2cce-48ce-acc6-2aa7f154c4ba	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER RASPBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	5443202c-4f88-4063-a227-c50abbd480d6	2025-08-08	Warnings	Exact identifier application number: M020
SUNSCREEN SPF50	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE	Guangzhou Tinsun Biotechnology Company Limited	3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e	2025-08-07	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