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 131 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral SunscreenZINC OXIDESPECKTRA6 LLC374f063a-1ea6-2fcc-e063-6394a90ac5742025-12-11Exact identifier
application number: M020
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
application number: M020
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b138432-19e5-e757-e063-6294a90a4cbe2025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b149758-bbe1-bd66-e063-6294a90afe782025-12-11WarningsExact identifier
application number: M020
Solar Shield Face and Body SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b14caa3-f58e-b9ab-e063-6394a90a96952025-12-11WarningsExact identifier
application number: M020
Solar Shield Primer SPF 40ZINC OXIDEBRIGHT SKINCARE, LLC3b152e27-3917-eb7e-e063-6394a90a1f432025-12-11WarningsExact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
application number: M020
Daytime Moisture SPF40ZINC OXIDECOLETTE TOMASI LLC372773b6-fc37-c74b-e063-6294a90a7bf22025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact 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