FDA.reportPublic FDA data

Soft Bisque Perfecting Makeup SPF 25

Product NDC
57627-130
11-digit product format
576270130
Labeler code
57627
Product ID
57627-130_5da9ef7d-4aac-82a4-e063-6294a90acbb2
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Titanium Dioxide
Dosage form
EMULSION
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-26
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
2.25; 2.13 g/30mL; g/30mL
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
Soft Bisque Perfecting Makeup SPF 25
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE2.25 g/30mL
TITANIUM DIOXIDE2.13 g/30mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-130-01Soft Bisque Perfecting Makeup SPF 25Merle Norman30 mL in 1 BOTTLEEMULSION3014
57627-130-02Soft Bisque Perfecting Makeup SPF 25Merle Norman1 in 1 CARTONEMULSION114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438USOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BASOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
ISODODECANEINACTIVE INGREDIENTA8289P68Y2SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51ESOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
SODIUM MYRISTOYL GLUTAMATEINACTIVE INGREDIENTAYU7QD893WSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ESOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6
WATERINACTIVE INGREDIENT059QF0KO0RSOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-130SOFT BISQUE PERFECTING MAKEUP SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]13Current NDC, Legacy NDC, 2 package rows20241006_e8b11940-6ac4-4c80-a732-2f86f2b7ebfe.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 6 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
application number: M020
Meraki Protective Mist SunscreenBROAD SPECTRUM SPF 30MERAKI MEDICAL SPA LLC59446224-0e97-ae2c-e063-6394a90a2a652026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsExact identifier
application number: M020
Sun Zapper - Anti-ageing pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3f1dc3b2-c289-5996-e063-6394a90ac6222026-08-16WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
HEB 50 Marigold Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.58dafa24-24d5-aeb4-e063-6394a90a3c252026-08-12WarningsExact identifier
application number: M020
TESALOVA Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONETesalova Viktoriia PMU LLC58dbb9f1-cfb3-62ac-e063-6394a90a61062026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
Basin Coconut SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e93a6-dcf9-3687-e063-6394a90a73ac2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Sonage Protec Plus SPF 30 Mineral SunscreenZINC OXIDEASA Universal Inc. dba: Sonaged92fc1df-bbeb-592a-e053-2a95a90a69512026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-130-015762701300130 mL in 1 BOTTLE30 mlHistorical
57627-130-02576270130021 BOTTLE in 1 CARTON (57627-130-02) / 30 mL in 1 BOTTLE (57627-130-01) 1 bottle2012-08-260000-00-00NoNoCurrent