Protectif Untinted

Product NDC: 82038-007
11-digit product format: 820380007
Labeler code: 82038
Product ID: 82038-007_1acd3232-7d83-8f27-e063-6294a90a0fb4
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: 2024-05-17
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 Untinted
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
1acd3f09-87f2-75e4-e063-6394a90a0cd9	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
82038-007-01	Protectif Untinted	100 g in 1 BOTTLE, PUMP	CREAM	100	1
82038-007-02	Protectif Untinted	1 in 1 CARTON	CREAM	1	1
82038-007-03	Protectif Untinted	30 g in 1 BOTTLE, PUMP	CREAM	30	1
82038-007-04	Protectif Untinted	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
82038-007	PROTECTIF UNTINTED (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]	1	Current NDC, 4 package rows	20240615_1acd3f09-87f2-75e4-e063-6394a90a0cd9.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 247 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	06ab109e-abcf-0861-e063-6394a90a9375	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465d-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d339273-6d82-0979-e063-6394a90a3de7	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc97b34-e9e6-ef6a-e063-6394a90aee89	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc9760b-b88b-f291-e063-6294a90a242f	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d338ec2-dca0-e032-e063-6394a90a69aa	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752d79d-5d82-0367-e063-6394a90a4f1c	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d33888d-20b3-f912-e063-6394a90a25dc	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465c-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a0-bafd-e063-6394a90a7a94	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0751b356-607f-f3cb-e063-6294a90a4092	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cace-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	07530636-cd21-3022-e063-6394a90a89d6	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0752753e-cac9-9166-e063-6394a90a4d8d	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06ad3c09-9f1b-b25c-e063-6294a90aebe1	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c57ff5-7013-d35f-e063-6394a90a6ee2	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b1f8bc-8b29-451a-e063-6294a90a34bd	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44de-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b26dd0-44ef-91a7-e063-6394a90a603a	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b25290-33a3-bafd-e063-6394a90a7a94	2024-12-25	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
82038-007-01	82038000701	100 g in 1 BOTTLE, PUMP	100 g				Historical
82038-007-02	82038000702	1 BOTTLE, PUMP in 1 CARTON (82038-007-02) / 100 g in 1 BOTTLE, PUMP (82038-007-01)		2024-05-17	No	No	Current
82038-007-03	82038000703	30 g in 1 BOTTLE, PUMP	30 g				Historical
82038-007-04	82038000704	1 BOTTLE, PUMP in 1 CARTON (82038-007-04) / 30 g in 1 BOTTLE, PUMP (82038-007-03)		2024-05-17	No	No	Current