Foundation Primer Plus SPF 15

Product NDC
57627-108
11-digit product format
576270108
Labeler code
57627
Product ID
57627-108_5da9729b-24d0-c556-e063-6394a90abc98
Type
HUMAN OTC DRUG
Nonproprietary name
octinoxate, octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-22
Substance
OCTINOXATE; OCTISALATE
Active strength
2.63; 1.75 g/35g; g/35g
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
Foundation Primer Plus SPF 15
Brand name suffix
MERLE NORMAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.63 g/35g
OCTISALATE1.75 g/35g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-108-01Foundation Primer Plus SPF 15MERLE NORMAN35 g in 1 TUBECREAM3517
57627-108-02Foundation Primer Plus SPF 15MERLE NORMAN1 in 1 BOXCREAM117
57627-108-03Foundation Primer Plus SPF 15MERLE NORMAN5 g in 1 TUBECREAM517
57627-108-04Foundation Primer Plus SPF 15MERLE NORMAN1 in 1 BOXCREAM117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
OCTISALATEACTIVE INGREDIENT4X49Y0596WFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
OCTINOXATEACTIVE MOIETY4Y5P7MUD51FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
OCTISALATEACTIVE MOIETY4X49Y0596WFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ5FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
PALMITOYL TRIPEPTIDE-1INACTIVE INGREDIENTHO4ZT5S86CFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
PEG-10 RAPESEED STEROLINACTIVE INGREDIENT258O76T85MFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0GFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCFOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-108FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS]16Current NDC, Legacy NDC, 4 package rows20241004_582ce0b2-addc-4b87-9334-c8f515b10a16.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 89 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE CORRECTING VEIL n MENSULIZOLE, OCTINOXATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION15a258a0-61c3-4419-bcdb-a8197d5ae46f2026-01-05WarningsExact identifier
application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
application number: M020
Poolside Butter Screen SPF 30 Sunscreen ButterHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCae838725-79ab-4c17-905b-d4138ad6af1f2026-01-05WarningsExact identifier
application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONEI World LLCb98a9cec-3c48-4614-b091-4e59fa7d196e2026-01-05WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC5a9f8888-529d-40d7-9489-baa5ff657cb42026-01-05WarningsExact identifier
application number: M020
Yon-Ka 50 Mineral FluidZINC OXIDELaboratoire MULTALER Yon-Ka47a8c8b2-30ff-0d40-e063-6294a90ac4612026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE EOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION6d2f82d5-b3af-44af-b6b0-de96a4cd95fc2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
application number: M020
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAYAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATESHISEIDO AMERICAS CORPORATION4a16dbb7-e860-4aae-8e8b-67abbe8295bd2026-01-05WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-108-015762701080135 g in 1 TUBE35 gHistorical
57627-108-02576270108021 TUBE in 1 BOX (57627-108-02) / 35 g in 1 TUBE (57627-108-01) 1 tube2011-04-220000-00-00NoNoCurrent
57627-108-03576270108035 g in 1 TUBE5 gHistorical
57627-108-04576270108041 TUBE in 1 BOX (57627-108-04) / 5 g in 1 TUBE (57627-108-03) 1 tube2011-04-220000-00-00NoNoCurrent