FDA.reportPublic FDA data

Powder

Product NDC
61354-188
11-digit product format
613540188
Labeler code
61354
Product ID
61354-188_41c09cb9-0e08-3abc-e063-6294a90a7883
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
TITANIUM DIOXIDE
Active strength
10 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
TITANIUM DIOXIDE10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
41c0c262-21c3-b8e6-e063-6394a90a7c9cAvailable 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
61354-188-01Powder1 in 1 CARTONPOWDER14
61354-188-01Powder100 mg in 1 CUPPOWDER1004

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 206 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Introstem Vitiscell Facial ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.65c28ed6-649d-41d9-b214-aab6ccb02dd52025-07-01WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d049b4-557f-724a-e063-6394a90a19b32025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.2f74965f-3c84-0590-e063-6294a90af2672025-06-30WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d0d165-e981-284a-e063-6294a90acace2025-06-30WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKINAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inca3dc6195-3011-4e7f-b1b0-0c815b11ba8d2025-06-30WarningsExact identifier
application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE AND OCTISALATELOreal USA Products Inc5712df74-5201-474b-bbfd-703f3117bd9c2025-06-30WarningsExact identifier
application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38bff6d0-5690-3ee5-e063-6294a90a9faa2025-06-29WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
application number: M020
Orchidee Double Defense Skin ShieldOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.74b3c33f-5db5-460d-97be-fa495b6252492025-06-27WarningsExact identifier
application number: M020
GHOSTEDZINC OXIDESpoogea5b611c3-d4d3-461e-84d8-d04a29c749022025-06-26WarningsExact identifier
application number: M020
Dew MeZINC OXIDESpooge0c4b429b-7dd5-4929-95af-d02b6770f1212025-06-26WarningsExact identifier
application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED38744f77-4845-eac4-e063-6294a90af6482025-06-26WarningsExact identifier
application number: M020
NYU Langone Health Lip BalmZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd38745b55-8da5-4627-e063-6394a90a24ca2025-06-26WarningsExact identifier
application number: M020
Active Skin Repair hydrating daily sunscreenZINC OXIDEInnovacyn, Inc.1eacdde1-f990-4962-92f1-3f41a8a3b1932025-06-26WarningsExact identifier
application number: M020
CheekyZINC OXIDESpooged377379a-a1be-4acf-9df5-2ff73fb5c83d2025-06-26WarningsExact identifier
application number: M020
TheOGZINC OXIDESpoogea2f781a8-eba8-48f5-8680-9235aae8a4ff2025-06-26WarningsExact identifier
application number: M020
Reef safe - Vitamin C sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0763-74e9-3a71-e063-6394a90a46fb2025-06-25WarningsExact identifier
application number: M020
Reef safe - acne-prone sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f079c-5730-5111-e063-6394a90af2d82025-06-25WarningsExact identifier
application number: M020
Reef safe - Zinc Face sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f0f79-016f-71a7-e063-6394a90a92862025-06-25WarningsExact identifier
application number: M020
Reef safe - Baby zinc sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f320c-9144-78b8-e063-6394a90a2e9d2025-06-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-188-01613540188011 CUP in 1 CARTON (61354-188-01) / 100 mg in 1 CUP1 cup2023-10-27NoNoCurrent