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 93 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Oil Free SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incded1f158-36d1-153f-e053-2995a90ace302025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08147940-0e8b-c894-e063-6394a90af8ac2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince468d703-fa6c-095a-e053-2a95a90a51942025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPL 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incdf4b522e-93d4-1284-e053-2a95a90a1cd92025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a40ff-a014-3995-e063-6394a90a11e62025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Ince451ecfb-cf17-c622-e053-2a95a90a4d4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact identifier
application number: M020
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc25d9c520-431a-5546-e063-6394a90a4e0d2025-12-31WarningsExact 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