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 100 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47387d5f-e77b-5633-e063-6294a90a55842025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738be66-0fe8-148e-e063-6394a90a1b022025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738eed1-9f72-5fd8-e063-6394a90a26bd2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4739179e-88b3-8820-e063-6394a90aa2112025-12-30WarningsExact identifier
application number: M020
WHITE TEA TINTED MOISTURIZERWHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREENGLOW CONCEPT INCeb2df93f-6cdc-7ae8-e053-2a95a90a00912025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
application number: M020
Calming Days Vegan Sunscreen,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEMERCYCO Co., Ltd.38898014-eefe-73ec-e063-6394a90a37382025-12-29WarningsExact identifier
application number: M020
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45SUNSCREEN OILSoleil Collective LLC471c0eed-f7ca-3c3b-e063-6294a90ad2c62025-12-29WarningsExact identifier
application number: M020
EIGHT HOUR NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
application number: M020
Prevage anti aging SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,Revlonb2bff796-1579-2686-e053-2995a90ad6c72025-12-29WarningsExact identifier
application number: M020
FLAWLESS FUTURE SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONEREVLONb553aec1-5002-3a3f-e053-2995a90a22e52025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging Moisture CreamOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONERevlon Consumer Products Corpb247adbe-dfe8-df0a-e053-2995a90a34d92025-12-29WarningsExact identifier
application number: M020
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
application number: M020
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact 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