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 25 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9c909ae0-0117-4675-afc2-533d542f36592026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CameoZINC OXIDEIris and Romeo52bc0174-872d-445b-e063-6294a90ab3292026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - IconicZINC OXIDEIris and Romeo52bbfdfe-dfc9-364f-e063-6294a90a646d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip Dew BronzeZINC OXIDEBloomeffects52bc7f23-3594-3173-e063-6294a90a81ea2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip DewZINC OXIDEBloomeffects0fcb1b45-c04d-310a-e063-6294a90ab56d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve MomentZINC OXIDEBloomeffects52bd7522-81b5-6189-e063-6394a90a29b42026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil BarelyZINC OXIDEBloomeffects52bd8a43-a8c2-897e-e063-6394a90a9f3d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact 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