FDA.reportPublic FDA data

Powder

Product NDC
61354-189
11-digit product format
613540189
Labeler code
61354
Product ID
61354-189_4d39fb2d-8fa3-07c9-e063-6394a90a0d4e
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
2025-07-25
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
4d39ed7a-ca80-893c-e063-6294a90a03e7Available 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
61354-189-01Powder1 in 1 CARTONPOWDER11
61354-189-01Powder100 mg in 1 CUPPOWDER1001

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 43 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.cf33c5a1-b7c5-4c5a-9981-e4e24208cd112026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.56c124d7-0b8c-4bb9-8261-c7395353fbe02026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Body Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.12b64f66-0ec0-4dde-9446-4151ae001ae42026-04-15WarningsExact identifier
application number: M020
Tula 24-7 Moisture Plus SPF 30 Hydrating Day with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, AND OCTISALATEPML NYC, LLC396dc7c7-a5e1-e1b2-e063-6294a90a75472026-04-15WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f87e24f-e4ff-03a7-e063-6294a90a23b12026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
application number: M020
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEGold Inti Trade Corporation4f6dd01e-21ab-0aa3-e063-6394a90a51f82026-04-14WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
application number: M020
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
application number: M020
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c0f2d9-3e2f-5358-e053-2995a90aeb842026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c2a37d-f52d-2fb0-e053-2a95a90a9bfa2026-04-14WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c3b1ef-0eae-6ac7-e053-2a95a90ac1dc2026-04-14WarningsExact identifier
application number: M020
NATURIUM Dew-Glow Moisturizer SPF 50NATURIUM DEW-GLOW MOISTURIZER SPF 50PML NYC, LLC00c93b11-754e-701c-e063-6294a90a3b1d2026-04-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEPML NYC, LLC1c3489a6-5b98-2dc2-e063-6294a90a06952026-04-14WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
application number: M020
SKINTIFIC OUTDOOR SUN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONELongway Technology(Guangzhou)Co.,Ltd.4f2c83e4-e656-f81e-e063-6394a90a4c682026-04-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-189-01613540189011 CUP in 1 CARTON (61354-189-01) / 100 mg in 1 CUP1 cup2025-07-25NoNoCurrent