Home NDC 57627-108 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 Ingredient Strength OCTINOXATE 2.63 g/35g OCTISALATE 1.75 g/35g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57627-108-01 Foundation Primer Plus SPF 15MERLE NORMAN 35 g in 1 TUBE CREAM 35 17 57627-108-02 Foundation Primer Plus SPF 15MERLE NORMAN 1 in 1 BOX CREAM 1 17 57627-108-03 Foundation Primer Plus SPF 15MERLE NORMAN 5 g in 1 TUBE CREAM 5 17 57627-108-04 Foundation Primer Plus SPF 15MERLE NORMAN 1 in 1 BOX CREAM 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 OCTISALATE ACTIVE MOIETY 4X49Y0596W FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 CAMELLIA OLEIFERA LEAF INACTIVE INGREDIENT 5077EL0C60 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 CERAMIDE 2 INACTIVE INGREDIENT C04977SRJ5 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 CYCLOMETHICONE 6 INACTIVE INGREDIENT XHK3U310BA FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 PALMITOYL TRIPEPTIDE-1 INACTIVE INGREDIENT HO4ZT5S86C FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 PEG-10 RAPESEED STEROL INACTIVE INGREDIENT 258O76T85M FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 TRIBEHENIN INACTIVE INGREDIENT 8OC9U7TQZ0 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 TRISILOXANE INACTIVE INGREDIENT 9G1ZW13R0G FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57627-108 FOUNDATION PRIMER PLUS SPF 15 MERLE NORMAN (OCTINOXATE, OCTISALATE) CREAM [MERLE NORMAN COSMETICS] 16 Current NDC, Legacy NDC, 4 package rows 20241004_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 25 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE LG H&H Co., Ltd. 52ba9423-8b9b-38f7-e063-6394a90a95da 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Frosted Petal ZINC OXIDE Odacite 52ba9423-8b9d-38f7-e063-6394a90a95da 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn ZINC OXIDE Iris and Romeo 52bb700b-ff56-2286-e063-6394a90ac458 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Camellia ZINC OXIDE Iris and Romeo 52bb52ec-2cd7-f8cc-e063-6294a90aa61b 2026-05-26 Warnings Exact identifier application number: M020 Bubble Solar Mate Daily Mineral Sunscreen SPF 40 ZINC OXIDE Bubble Beauty, Inc. d2eca90f-9463-4d2f-975d-02f2802ded3e 2026-05-26 Warnings Exact identifier application number: M020 Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30 ZINC OXIDE Plexus Worldwide, LLC 55c391fa-37c6-47a2-befd-12888eb5fc18 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Suede ZINC OXIDE Iris and Romeo 52bb7505-a027-2533-e063-6294a90a2520 2026-05-26 Warnings Exact identifier application number: M020 Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 9c909ae0-0117-4675-afc2-533d542f3659 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Carob ZINC OXIDE Iris and Romeo 52bbe9da-37f8-b3ba-e063-6394a90a139e 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Cameo ZINC OXIDE Iris and Romeo 52bc0174-872d-445b-e063-6294a90ab329 2026-05-26 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Moisture Lip Balm - Iconic ZINC OXIDE Iris and Romeo 52bbfdfe-dfc9-364f-e063-6294a90a646d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulip Dew Bronze ZINC OXIDE Bloomeffects 52bc7f23-3594-3173-e063-6294a90a81ea 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulip Dew ZINC OXIDE Bloomeffects 0fcb1b45-c04d-310a-e063-6294a90ab56d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment ZINC OXIDE Bloomeffects 52bd7522-81b5-6189-e063-6394a90a29b4 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Barely ZINC OXIDE Bloomeffects 52bd8a43-a8c2-897e-e063-6394a90a9f3d 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Fruit Punch ZINC OXIDE Bloomeffects 52bdc0ec-ac5e-4a57-e063-6294a90a0b3b 2026-05-26 Warnings Exact identifier application number: M020 Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy Pink ZINC OXIDE Bloomeffects 52bdc5cc-9742-4af6-e063-6294a90aba22 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Daylight ZINC OXIDE NewAlley Innovations Inc 52be1071-67cb-f2c0-e063-6294a90a368c 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Hazy ZINC OXIDE NewAlley Innovations Inc 52be3c9e-a791-5053-e063-6294a90a1b30 2026-05-26 Warnings Exact identifier application number: M020 Alleyoop Sun Serum Lip Oil - Whirlwind ZINC OXIDE NewAlley Innovations Inc 52be633a-fc64-7456-e063-6294a90a8fc0 2026-05-26 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57627-108-01 57627010801 35 g in 1 TUBE 35 g Historical 57627-108-02 57627010802 1 TUBE in 1 BOX (57627-108-02) / 35 g in 1 TUBE (57627-108-01) 1 tube 2011-04-22 0000-00-00 No No Current 57627-108-03 57627010803 5 g in 1 TUBE 5 g Historical 57627-108-04 57627010804 1 TUBE in 1 BOX (57627-108-04) / 5 g in 1 TUBE (57627-108-03) 1 tube 2011-04-22 0000-00-00 No No Current