FDA.reportPublic FDA data

Powder

Product NDC
61354-119
11-digit product format
613540119
Labeler code
61354
Product ID
61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-27
Substance
FERRIC OXIDE RED; TITANIUM DIOXIDE
Active strength
1.75; 10 mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2027-12-31
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
Powder
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED1.75 mg/100mg
TITANIUM DIOXIDE10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08b8003f-40be-3380-e063-6294a90a4f6bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-119-01Powder100 mg in 1 CUPPOWDER1003
61354-119-02Powder1 in 1 CARTONPOWDER13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-119POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]2Current NDC, 2 package rows20250508_08b8003f-40be-3380-e063-6294a90a4f6b.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 292 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffe-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchistix, LLC1d78148a-586c-2f7d-e063-6294a90a46912024-07-17WarningsExact identifier
application number: M020
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
application number: M020
CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfa412c9d-2a8b-bf71-e053-6394a90a8a632024-07-16WarningsExact identifier
application number: M020
CVS Health SPF 50 ClearAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf42402ff-0d70-9231-e053-2995a90aa46d2024-07-16WarningsExact identifier
application number: M020
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
application number: M020
NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6ca01ccb-07f8-4d2c-84bb-6b251e73dad22024-07-16WarningsExact identifier
application number: M020
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC1d4cab02-8897-6449-e063-6294a90ad72e2024-07-15WarningsExact identifier
application number: M020
the beach people SPF 50ZINC OXIDEThe Beach People United LLC2e5176e2-e2f4-4b08-8528-cb1ee3c166592024-07-15WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production23235897-c1fc-423f-99a2-e2ad282ee7442024-07-14WarningsExact identifier
application number: M020
LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc96d72471-de95-4668-8903-aed6187633a92024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDECosmetique Active Productiona3b5dfe5-c726-4f9c-8e4d-0e9808480d4b2024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDELOreal USA Products Inc2e85cf6e-a2a7-4871-bdb6-1d72088c30312024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc664c67cc-7d63-45d7-abdd-157c041b0d3f2024-07-14WarningsExact identifier
application number: M020
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Inc817c882d-72f3-4ee7-8da2-a4a32f9d167f2024-07-14WarningsExact identifier
application number: M020
Sun Wrangler Daily Mineral Sunscreen SPF 45ZINC OXIDESun Wrangler1d0e94f1-2996-c058-e063-6294a90a343b2024-07-12WarningsExact identifier
application number: M020
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
application number: M020
the beach people SPF 30ZINC OXIDEThe Beach People United LLC3a7cc69a-6027-4dfd-b9ef-9d4390fe630c2024-07-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-119-0161354011901100 mg in 1 CUP100 mgHistorical
61354-119-02613540119021 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01) 1 cup2023-10-27NoNoCurrent