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 26 of 357 · 7,139 matching rows.
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