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 225 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDEThe Creme Shop30a4280b-4a9f-4c18-e063-6394a90a85e62025-03-18WarningsExact identifier
application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45ZINC OXIDEEai-jr 286, Inc30a5ec14-63d7-e678-e063-6294a90abb572025-03-18WarningsExact identifier
application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc88e44da-0b0e-4744-8b4b-4d9d418f29d72025-03-18WarningsExact identifier
application number: M020
MDP UV BIO SUNSCREENZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATESKINIDEA CO., LTD3087771e-2ab8-2198-e063-6294a90a37d42025-03-17WarningsExact identifier
application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.2b38da59-b83e-4285-e063-6294a90ac6a72025-03-17WarningsExact identifier
application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
application number: M020
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
application number: M020
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50ZINC OXIDELG H&H CO., LTD.2b4c363b-f767-7901-e063-6394a90adba52025-03-13WarningsExact identifier
application number: M020
Zinc OxideMINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREENVege Labs LLC303e84e1-3bea-ea6f-e063-6294a90aeaa72025-03-13WarningsExact identifier
application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATEHaikou Pucao Trading Co.,Ltd303f7dd6-aef2-30ce-e063-6394a90ac00f2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE SAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION1a304bf0-dcda-4887-9738-54ce35ca503b2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMERAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION805fd75e-3c53-4ddd-afdc-a65f921822d42025-03-13WarningsExact identifier
application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC10abc330-7d45-4049-b80a-dbf58374187e2025-03-12WarningsExact identifier
application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC462acd16-b9c0-4f02-b297-d9b54036b5312025-03-12WarningsExact identifier
application number: M020
HAWAIIAN TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50ZINC OXIDETopiderm, Inc.1af53e89-debe-4f4c-b0ef-eec2073228df2025-03-07WarningsExact 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