FDA.reportPublic FDA data

Prevention

Product NDC
85463-203
11-digit product format
854630203
Labeler code
85463
Product ID
85463-203_45b4ce38-f5cf-ce87-e063-6394a90af902
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Noble Center for Healthy Aging LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-03
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Prevention
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
387dbf46-4316-a15d-e063-6394a90adeb1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85463-203-50Prevention53 g in 1 BOTTLE, PUMPCREAM532

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 162 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
application number: M020
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
application number: M020
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
application number: M020
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
application number: M020
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
application number: M020
Baby Bare Republic Mineral SunscreenZINC OXIDECOOLA, LLCb292d1a9-7ff8-0faf-e053-2995a90ae3422025-11-14WarningsExact identifier
application number: M020
Aspen Islanders Sheer Mineral SportZINC OXIDEAspen Islanders LLC0fcb2adf-71c9-3369-e063-6294a90aa8062025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE MALON DAZEBy the Beach Suncare LLC4391728b-dfe7-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CITRUS CRUSHBy the Beach Suncare LLC43918d25-e947-5e17-e063-6394a90ada7c2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CANDY CLOUDSBy the Beach Suncare LLC4391728b-dfe8-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Balance and ClearZINC OXIDESunsolve MD Inc26f3595d-adef-a8a5-e063-6394a90adfd42025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Detox and ShieldZINC OXIDESunsolve MD Inc26f3886b-a3a5-c9b7-e063-6394a90af6c32025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Amber 002ZINC OXIDESunsolve MD Inc26e00001-9c68-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Agate 003ZINC OXIDESunsolve MD Inc26e00001-9c6f-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Bronzite 004ZINC OXIDESunsolve MD Inc26e13356-9ab5-246a-e063-6394a90a2a702025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Onyx 006ZINC OXIDESunsolve MD Inc26e16b5e-dd2e-6fb8-e063-6394a90a6a7f2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Calm and RevitalizeZINC OXIDESunsolve MD Inc26f3f534-a305-3530-e063-6394a90a75e12025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Garnet 005ZINC OXIDESunsolve MD Inc26e1508f-d386-329b-e063-6394a90a0a982025-11-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85463-203-508546302035053 g in 1 BOTTLE, PUMP (85463-203-50) 53 g2021-05-03NoNoCurrent