FDA.reportPublic FDA data

Lasting Foundation SPF 12

Product NDC
57627-110
11-digit product format
576270110
Labeler code
57627
Product ID
57627-110_5da97f3a-6cf8-f99e-e063-6294a90af96e
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-22
Substance
TITANIUM DIOXIDE
Active strength
2.4 g/30g
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
Lasting Foundation SPF 12
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.4 g/30g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-110-01Lasting Foundation SPF 12Merle Norman30 g in 1 TUBECREAM3016
57627-110-02Lasting Foundation SPF 12Merle Norman1 in 1 BOXCREAM116

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
ETHYLENE BRASSYLATEINACTIVE INGREDIENT9A87HC7RODLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
ISODODECANEINACTIVE INGREDIENTA8289P68Y2LASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ELASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51ELASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZLASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-110LASTING FOUNDATION SPF 12 MERLE NORMAN (TITANIUM DIOXIDE) CREAM [MERLE NORMAN COSMETICS, INC]15Current NDC, Legacy NDC, 2 package rows20241004_d31cfc74-7dcf-4af1-ba53-63fcad414464.zip

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 42 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f970778-97d6-40a9-e063-6394a90a6c892026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-110-015762701100130 g in 1 TUBE30 gHistorical
57627-110-02576270110021 TUBE in 1 BOX (57627-110-02) / 30 g in 1 TUBE (57627-110-01) 1 tube2011-04-220000-00-00NoNoCurrent