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		2026-10-27
excluded package	package	82038-002	82038-002-02	I	Inactivated by FDA		2026-10-27

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 183 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	053e76f0-8ca0-645d-e063-6394a90a01d2	2025-09-28	Warnings	Exact identifier application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30	ZINC OXIDE	Edgewell Personal Care Brands LLC	cdc54f23-0efb-2fb4-e053-2995a90ae58b	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	0540017a-52ac-7972-e063-6394a90a139c	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	08f3b27f-b233-d406-e063-6394a90ada76	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	128a3772-b9b7-0d10-e063-6294a90a3e05	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c82a2-0131-8023-e063-6294a90aba7b	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c780a-3107-d71a-e063-6394a90aca25	2025-09-28	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	31d01fae-4085-d84a-e063-6294a90ab981	2025-09-28	Warnings	Exact identifier application number: M020
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	3388c2fa-8082-95d4-e063-6294a90a94b8	2025-09-28	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	b10a7794-7e4f-412b-9eb2-773107ecb7fc	2025-09-26	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50	HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%	Black Girl Sunscreen	fed22570-e0ae-43e1-b6ce-1f0ad01684c3	2025-09-26	Warnings	Exact identifier application number: M020
Smooth Even Glow	TINTED SUNSCREEN BROAD SPF30	SKNVcare, LLC	3fa48151-fcb9-3d35-e063-6394a90a2eb6	2025-09-25	Warnings	Exact identifier application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVE	AVOBENZONE, HOMOSALATE, OCTISALATE	MDSolarSciences	3fa810b0-0211-f2a7-e063-6294a90a0b72	2025-09-25	Warnings	Exact identifier application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREEN	ZINC OXIDE/TITANIUM DIOXIDE	SPF Ventures, LLC	3f874062-ebab-8993-e063-6294a90abfc5	2025-09-24	Warnings	Exact identifier application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50	ZINC OXIDE	HYGIENELAB, INC	7db103da-b434-433a-a18f-a727165640c0	2025-09-24	Warnings	Exact identifier application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen	HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE	Space Brands Limited	0e2c9ffb-036d-49c5-abdb-2ee8888df318	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint DG6	ZINC OXIDE	PUR Minerals	3f8e97a7-2023-ba9c-e063-6294a90ac9c9	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint TN7	ZINC OXIDE	PUR Minerals	3f0717c7-f43f-e3b1-e063-6394a90a74dd	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint TN2	ZINC OXIDE	PUR Minerals	3f06ed2f-f43f-53d4-e063-6294a90af0dd	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint MN4	ZINC OXIDE	PUR Minerals	3f06f618-f7b2-53d0-e063-6294a90a829c	2025-09-24	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
82038-002-01	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