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 242 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 CaramelZINC OXIDEEVER FAME PTE. LTD.2abc2ce2-bf4d-4efd-e063-6294a90ae9882025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CashewZINC OXIDEEVER FAME PTE. LTD.2abc9c3c-2a0f-6838-e063-6394a90ac4f22025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ChantillyZINC OXIDEEVER FAME PTE. LTD.2abcaa9e-2f93-44a8-e063-6394a90a76442025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 EarthZINC OXIDEEVER FAME PTE. LTD.6d801c70-2954-408a-a023-bf9ed7b3aaa82025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ChesnutZINC OXIDEEVER FAME PTE. LTD.2abc95a2-0f4a-8d52-e063-6294a90a102c2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Dark CloveZINC OXIDEEVER FAME PTE. LTD.2abcddde-f160-f7df-e063-6294a90a0f982025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 CocoaZINC OXIDEEVER FAME PTE. LTD.2abc98e3-079e-5797-e063-6394a90aff602025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Deep CoffeeZINC OXIDEEVER FAME PTE. LTD.2abcf16f-52d6-3f91-e063-6294a90a84ef2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 FairZINC OXIDEEVER FAME PTE. LTD.2abcfc81-c860-0e8d-e063-6294a90a0f422025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 HoneyZINC OXIDEEVER FAME PTE. LTD.2abd4192-fee2-ca74-e063-6294a90a1e1d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 GoldenZINC OXIDEEVER FAME PTE. LTD.2abcf16f-5320-3f91-e063-6294a90a84ef2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 HazelnutZINC OXIDEEVER FAME PTE. LTD.2abd4192-fee0-ca74-e063-6294a90a1e1d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 LinenZINC OXIDEEVER FAME PTE. LTD.2abd4227-4fcf-266c-e063-6394a90a293b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 MahoganyZINC OXIDEEVER FAME PTE. LTD.2abd75c3-554a-d428-e063-6294a90ae77d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 MochaZINC OXIDEEVER FAME PTE. LTD.2abd75c3-554f-d428-e063-6294a90ae77d2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 NudeZINC OXIDEEVER FAME PTE. LTD.2abd8527-72a5-1564-e063-6294a90ad8d32025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 NutmegZINC OXIDEEVER FAME PTE. LTD.2abdda5e-0f52-ae46-e063-6394a90ae6f52025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PorcelainZINC OXIDEEVER FAME PTE. LTD.2abdddbc-d891-7c4d-e063-6294a90a81622025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 RussetZINC OXIDEEVER FAME PTE. LTD.2abe084b-7478-e923-e063-6394a90ac9412025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PeachZINC OXIDEEVER FAME PTE. LTD.2abdca50-ffc4-8c36-e063-6394a90af7662025-01-02WarningsExact 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