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 339 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peppermint SPF 15 Broad Spectrum Lip BalmPEPPERMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901a7f7-af83-0aa1-e053-2995a90aa32b2023-10-18WarningsExact identifier
application number: M020
Mineral SPF 15 Broad Spectrum Lip BalmMINERAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc44d2759a-d95d-7525-e054-00144ff88e882023-10-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d2023-10-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productiond60887aa-7586-4d4b-88af-35b4f982aacf2023-10-18WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Protection SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLCd13da7be-a419-4416-96be-8421665dbd822023-10-17WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALMRaining Roseefe27e7e-e805-1c47-e053-2995a90af22e2023-10-17WarningsExact identifier
application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25AVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLCf1109f0e-ebf5-450e-8a4e-b314a91b24832023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC8c7c0e3f-6092-413c-90f1-b3466c8a95012023-10-13WarningsExact identifier
application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar SmartOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC3d23406b-5252-4ab0-b666-77c0132b0d002023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC94274343-3892-4c27-9d2f-c025310e29592023-10-13WarningsExact identifier
application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGYOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCe557e7f3-1fa7-4dde-977f-fe3f942496c02023-10-13WarningsExact identifier
application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC68cfcbc2-a214-437e-9956-f77c90d748882023-10-13WarningsExact identifier
application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC159410d4-4479-4442-b371-bde72aae3e1e2023-10-13WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-ProtectionHOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDELaboratoires Clarins0695e3a4-0e8f-419e-b128-9b02bdb8b02a2023-10-11WarningsExact identifier
application number: M020
Orange Soda SPF 15 Broad Spectrum Lip BalmORANGE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c362ae-b878-c630-e053-2995a90ad4c42023-10-10WarningsExact identifier
application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVBZINC OXIDESkin Laundry Holdings, Inc.071038d9-8179-6953-e063-6394a90a8a842023-10-06WarningsExact identifier
application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST4bae83b7-2c98-4928-8e71-bb4f19cc48f02023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 LightZINC OXIDE TITANIUM DIOXIDEBurt's Bees3150ef71-2ea1-25d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 MediumZINC OXIDE TITANIUM DIOXIDEBurt's Bees3346f41e-32d0-35d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC59eeb180-1ac6-44b3-9742-dc65287896bf2023-10-05WarningsExact 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