FDA.reportPublic FDA data

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 82 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact identifier
application number: M020
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact 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