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 115 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
application number: M020
Eucerin Radiant ToneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc2611e0cb-d56d-6ea1-e063-6294a90a745b2025-12-16WarningsExact identifier
application number: M020
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEKLOE SALON LLC36c23c07-2011-3ddb-e063-6294a90a76e92025-12-16Exact identifier
application number: M020
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
application number: M020
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
application number: M020
Replenishing Daily SunscreenZINC OXIDEBABYFACE LLC36d773d7-349d-68c1-e063-6394a90aff1e2025-12-16Exact identifier
application number: M020
TiZO Tinted Moisturizing Serum - LightZINC OXIDEFallien Cosmeceuticals, Ltd.2d44158a-44b3-5a3d-e063-6294a90a1f162025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Light-MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d53071f-0275-d00c-e063-6294a90afcca2025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d550967-25af-3e7a-e063-6394a90a2c792025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Medium-DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d57790c-22cf-08aa-e063-6394a90aeac02025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d5813e8-a219-db90-e063-6294a90a6ca72025-12-16WarningsExact 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