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 215 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 CLEARLIP 30 CLEARThe Center Brands, LLC33d5d1d4-c516-238c-e063-6294a90ac11c2025-04-28WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBEL STAR SA33db89ac-2653-78f5-e063-6394a90af03d2025-04-28WarningsExact identifier
application number: M020
LifeguardSUNSCREENSPHERE 8 INC32be4eb3-f106-182d-e063-6394a90aa4842025-04-28WarningsExact identifier
application number: M020
Practical Alchemy Purify and Protect DuoMICELLAR WATER WIPES AND ZINC OXIDEOver Here, LLC28514e58-59a6-094a-e063-6394a90a1c7d2025-04-28WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380a271-1538-2e3a-e063-6294a90a90a22025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd3380f1ac-0320-35f2-e063-6394a90a97eb2025-04-24WarningsExact identifier
application number: M020
BEEF TALLOW SUNSCREENZINC OXIDE 15%Yunqi Cosmetics (Shenzhen) Co., Ltd33813fe1-8496-d541-e063-6294a90a62542025-04-24WarningsExact identifier
application number: M020
Sunstation Sport Sunscreen SPF 30OCTISALATE, OCTOCRYLENE, ZINC OXIDEImpact Melanoma Incba78aa73-a25b-4a8e-99b2-9262bb9a7d272025-04-24WarningsExact identifier
application number: M020
Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company42819c8d-cc0a-4bee-95db-39a69ce7f6602025-04-24WarningsExact identifier
application number: M020
LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.338c2c66-497a-f7d1-e063-6294a90a77892025-04-24WarningsExact identifier
application number: M020
The Ordinary UV Filters SPF 45 SerumHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATEDeciem10cde253-26ee-b97d-e063-6394a90a83022025-04-23WarningsExact identifier
application number: M020
BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin CZINC OXIDEVeganicSKN3123aab6-0407-19e5-e063-6394a90a5bd82025-04-23WarningsExact identifier
application number: M020
Sephora Daily Sunscreen Cream Broad Spectrum SPF 30ZINC OXIDES+b49e043b-8164-421c-a02b-3dab0be1454d2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Sports CreamZINC OXIDEYAYA ORGANICS L.L.C.9eabf1f8-698b-4fa8-98d3-3696c35b044c2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Baby Kids Mineral SunscreenZINC OXIDEYAYA ORGANICS L.L.C.3275303d-a448-4fb4-bdce-6442823f89962025-04-22WarningsExact identifier
application number: M020
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
application number: M020
Back9ine Skincare Pure Invisible Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBack 9ine Skincare, LLC974ede40-cfb5-4612-b168-5d42dd137f632025-04-22WarningsExact 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