FDA.reportPublic FDA data

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
IngredientStrength
TITANIUM DIOXIDE6.5 g/100g
ZINC OXIDE8.6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
19b19023-1340-6609-e063-6394a90a6eafAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82038-005-01Protectif Deep Tint100 g in 1 BOTTLE, PUMPCREAM1001
82038-005-02Protectif Deep Tint1 in 1 CARTONCREAM11
82038-005-03Protectif Deep Tint30 g in 1 BOTTLE, PUMPCREAM301
82038-005-04Protectif Deep Tint1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82038-005PROTECTIF DEEP TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]1Current NDC, 4 package rows20240601_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 247 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENERevlon Consumer Products Corp012be422-1b4c-443c-9484-02efc744296d2024-12-30WarningsExact identifier
application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATEREVLON2a857553-5ad0-a0e2-e063-6294a90af4352024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.713bad2e-bf32-4cd5-9630-b8d88d4376862024-12-30WarningsExact identifier
application number: M020
Protection 50 SportHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e9ace96a-7717-4f5a-8e1b-1f56f74985992024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 SunscreenOCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdf62e1c2-ce72-4ded-8985-156dce9ff41d2024-12-28WarningsExact identifier
application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc02dddfc5-61e6-433b-8d6d-a17bf3fc8ed62024-12-28WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production229eef79-39ae-4395-8100-64d1ece960d22024-12-28WarningsExact identifier
application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30ZINC OXIDECOOLA LLCbb9dd9a9-ec01-4e94-9172-3a72e68a417a2024-12-27WarningsExact identifier
application number: M020
Bare Republic Mineral SPF 50ZINC OXIDECOOLA LLC6a0db9da-ee45-4ab7-80de-4bf189efe75f2024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLC9a397a2c-4734-4dae-93dd-15c68e6c297d2024-12-27WarningsExact identifier
application number: M020
Refreshing Water Hydration Stick SPF 50AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENECOOLA LLC6da037f8-bedb-467a-b534-e44752120f2c2024-12-27WarningsExact identifier
application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.649a9c28-bfd4-404c-90d5-5d0ea8c7b6452024-12-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
application number: M020
PORESCREEN SPF40ZINC OXIDEDermalogica, LLC.37a7362a-b251-4d3a-a957-65d8f338fa122024-12-27WarningsExact identifier
application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC12ff4689-f7e2-49db-8848-608c61b41ef02024-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82038-005-0182038000501100 g in 1 BOTTLE, PUMP100 gHistorical
82038-005-02820380005021 BOTTLE, PUMP in 1 CARTON (82038-005-02) / 100 g in 1 BOTTLE, PUMP (82038-005-01) 2024-05-09NoNoCurrent
82038-005-038203800050330 g in 1 BOTTLE, PUMP30 gHistorical
82038-005-04820380005041 BOTTLE, PUMP in 1 CARTON (82038-005-04) / 30 g in 1 BOTTLE, PUMP (82038-005-03) 2024-05-09NoNoCurrent