FDA.reportPublic FDA data

DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted

Product NDC
82240-424
11-digit product format
822400424
Labeler code
82240
Product ID
82240-424_09e30a62-356e-3cff-e063-6394a90a270f
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
DERMAKA SKIN PRODUCTS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-02
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 110 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE110 mg/mL

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
9aa24e1f-e338-4947-a437-554fb6b227a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82240-424-00DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted100 mL in 1 TUBECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82240-424DERMAKA BROAD SPECTRUM SPF-42 SUNSCREEN UNTINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [DERMAKA SKIN PRODUCTS]2Current NDC, 1 package rows20231116_9aa24e1f-e338-4947-a437-554fb6b227a2.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 173 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avinichi Noni Sol Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.9e534e32-efea-4dcf-adc1-18de3847ac042025-10-30WarningsExact identifier
application number: M020
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDETHG Beauty USA LLC1cd10158-c346-60c9-e063-6294a90a54bd2025-10-29WarningsExact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
application number: M020
Hello Bello Kids Mineral SunscreenZINC OXIDE TITANIUM OXIDEHello Bello3e7a3e8e-eacf-0a30-e063-6294a90ab7ec2025-10-29WarningsExact identifier
application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
application number: M020
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact identifier
application number: M020
KidsBliss Baby and Kids Mineral Sunscreen SPF50ZINC OXIDEVeganicSKN2dfa236f-128b-17bb-e063-6294a90aa29c2025-10-24WarningsExact identifier
application number: M020
Oze Sun Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd7477-445f-d1d5-e063-6394a90a46072025-10-24WarningsExact identifier
application number: M020
Oze Sun reef safe Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd936b-0ea6-03a2-e063-6394a90a4fba2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 yearsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de1cd7-fdfd-7f7a-e063-6394a90a9b5c2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adultZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de09dc-544f-9780-e063-6394a90acd272025-10-24WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
application number: M020
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
application number: M020
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30ZINC OXIDEThrive Natural Care, Inc128e1a3a-df40-f51c-e063-6394a90a19022025-10-23WarningsExact identifier
application number: M020
Thrive Bodyshield 50 SPF 50ZINC OXIDEThrive Natural Care, Inc12d9e1d0-c59c-f770-e063-6294a90a81912025-10-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82240-424-0082240042400100 mL in 1 TUBE (82240-424-00) 100 ml2023-10-02NoNoCurrent