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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H.E.B Solutions SunscreenCOCONUT PINEAPPLE SCENTED SPF 50 STICKH.E.B29aef42c-f617-4c56-a166-8e1f0d6dbfd02021-07-09WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm BeigeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS58465981-e84c-4eaf-b7d5-fad1666f63fc2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 BambooOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASb2259b27-e1a5-482c-8916-356c1ee9774a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply BronzeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS199dde64-1dd3-4eb6-baef-261c97162f792021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 CremeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS753c34f2-3cb8-4df7-9aeb-ea926fb0279a2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 DuneOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS745dd675-86ee-4acc-8333-4870e0a57c752021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 LatteOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASe66734e4-34e7-4674-bb98-bdca931a176d2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SandOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASbf78f7a7-93ca-425e-8571-175da6798e8e2021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 SepiaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS418cdd4a-23f7-4181-b734-5ab7456494a22021-06-29WarningsExact identifier
application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ToffeeOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS50138c51-f424-4b07-b3eb-c0d31d8ecf162021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 CameoOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS01a861b9-0ab6-4c4c-a407-428a64509a1c2021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 BirchOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd5431d62-fded-4cdc-81a1-5b5e3eb928732021-06-29WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 TawnyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS52c3378f-6b99-42fa-900e-8a693864c6152021-06-29WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenFACE SPF 70 LOTIONH.E.B73b49068-953b-496d-8ea9-404df7e790892021-01-19WarningsExact identifier
application number: M020
Think Every Day Face Sunscreen SPF 30ZINC OXIDEthinkOperations,LLCafed91dd-8544-4b4b-e053-2995a90a2d162020-09-22WarningsExact identifier
application number: M020
THINKSPORT Kids sunscreen SPF 50ZINC OXIDEthinkOperations,LLC8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d2020-09-08WarningsExact identifier
application number: M020
THINKBABY Baby Sunscreen SPF 50ZINC OXIDEthinkOperations,LLC820317d2-1803-4949-bddf-09521a5d17502020-09-08WarningsExact identifier
application number: M020
THINKSPORT sunscreen SPF 50ZINC OXIDEthinkOperations,LLC6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea2020-08-03WarningsExact identifier
application number: M020
ESSENTIALS Face and Body SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsdfc44a01-e8fd-43fc-b3cd-5cac17e4a5a32020-04-02WarningsExact identifier
application number: M020
Thinksport Sunscreen SPF 18ZINC OXIDEthinkOperations,LLC9cd5010c-0b23-2888-e053-2995a90adb722020-01-23WarningsExact 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