Protectif Deep Tint

Product NDC: 82038-005
11-digit product format: 820380005
Labeler code: 82038
Product ID: 82038-005_19b18cbb-b098-266a-e063-6294a90a81a8
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 DRUG
Marketing start: 2024-05-09
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 6.5; 8.6 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Protectif Deep Tint
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	6.5 g/100g
ZINC OXIDE	8.6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19b19023-1340-6609-e063-6394a90a6eaf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82038-005-01	Protectif Deep Tint	100 g in 1 BOTTLE, PUMP	CREAM	100	1
82038-005-02	Protectif Deep Tint	1 in 1 CARTON	CREAM	1	1
82038-005-03	Protectif Deep Tint	30 g in 1 BOTTLE, PUMP	CREAM	30	1
82038-005-04	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
82038-005	PROTECTIF DEEP TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Current NDC, 4 package rows	20240601_19b19023-1340-6609-e063-6394a90a6eaf.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 255 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BabyGanics Sunscreen 30 SPF	ZINC OXIDE, OCTINOXATE, AND OCTISALATE	KAS Direct LLC dba BabyGanics	391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 PORCELAIN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ac9a5-f609-d804-e063-6394a90abd05	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 IVORY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299ad424-16a8-66b1-e063-6394a90a0753	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NUDE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afef9-758f-74e1-e063-6294a90a8072	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 NATURAL BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3276-7973-d33f-e063-6294a90a6ce1	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CLASSIC TAN	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299afe24-d496-5745-e063-6394a90aa1b3	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 WARM BEIGE	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b1f9a-34fd-cb50-e063-6394a90af925	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SOFT SAND	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b3236-3f3d-c9e8-e063-6394a90a7443	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 TAWNY	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	299b416d-ce02-3462-e063-6294a90a38f0	2024-12-19	Warnings	Exact identifier application number: M020
Puttisu	TITANIUM DIOXIDE, ZINC OXIDE	Jellycup, Inc.	a032331a-6724-d2cd-e053-2995a90ac15a	2024-12-19	Warnings	Exact identifier application number: M020
Dr. C. Tuna Resurface Essential Day Cream SPF 30	HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE	Farmasi US LLC	de493e30-d135-9def-e053-2995a90ae49a	2024-12-19	Warnings	Exact identifier application number: M020
toty Ilumina CC Cream 1N	TITANIUM DIOXIDE, ZINC OXIDE	Chipican LLC	e4efe14e-7d46-78c0-e053-2995a90a2364	2024-12-19	Warnings	Exact identifier application number: M020
Aruba Sun SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d8b28ce6-e938-c6e3-e053-2a95a90acc29	2024-12-19	Warnings	Exact identifier application number: M020
DCH Pain Relief Roll-On	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	fda35d37-f36e-efc8-e053-6294a90a2bb8	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 50 Kids	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d53ff8f5-0b06-1e8b-e053-2a95a90ab924	2024-12-19	Warnings	Exact identifier application number: M020
Fresh Coast SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	043cadde-ba07-7c77-e063-6394a90abee6	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Derma Care Research Labs, LLC	d438be95-0f88-69d7-e053-2995a90a982e	2024-12-19	Warnings	Exact identifier application number: M020
Pavin SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	e945f9df-0aed-469c-e053-2995a90ab6aa	2024-12-19	Warnings	Exact identifier application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%	Derma Care Research Labs, LLC	051b68f9-5d6b-3cd7-e063-6394a90aeb35	2024-12-19	Warnings	Exact identifier application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	484e92db-09a2-4e93-aa7e-d91dbda31555	2024-12-19	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	Sample	Exclude flag	Status
82038-005-01	82038000501	100 g in 1 BOTTLE, PUMP	100 g				Historical
82038-005-02	82038000502	1 BOTTLE, PUMP in 1 CARTON (82038-005-02) / 100 g in 1 BOTTLE, PUMP (82038-005-01)		2024-05-09	No	No	Current
82038-005-03	82038000503	30 g in 1 BOTTLE, PUMP	30 g				Historical
82038-005-04	82038000504	1 BOTTLE, PUMP in 1 CARTON (82038-005-04) / 30 g in 1 BOTTLE, PUMP (82038-005-03)		2024-05-09	No	No	Current