FDA.reportPublic FDA data

Vanilla Perfecting Makeup Broad Spectrum SPF 25

Product NDC
57627-124
11-digit product format
576270124
Labeler code
57627
Product ID
57627-124_5da9b909-3c72-fc30-e063-6394a90a3207
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
2012-08-22
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
Vanilla Perfecting Makeup Broad Spectrum 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
57627-124-01Vanilla Perfecting Makeup Broad Spectrum SPF 25Merle Norman30 mL in 1 BOTTLEEMULSION309
57627-124-02Vanilla Perfecting Makeup Broad Spectrum SPF 25Merle Norman1 in 1 CARTONEMULSION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ISODODECANEINACTIVE INGREDIENTA8289P68Y2VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SODIUM MYRISTOYL GLUTAMATEINACTIVE INGREDIENTAYU7QD893WVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RVANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-124VANILLA PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]8Current NDC, Legacy NDC, 2 package rows20241006_98ebaa5c-ba28-4e70-a45c-6545eb756d8f.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 173 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDETHG Beauty USA LLC1cd10158-c346-60c9-e063-6294a90a54bd2025-10-29WarningsExact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
application number: M020
Hello Bello Kids Mineral SunscreenZINC OXIDE TITANIUM OXIDEHello Bello3e7a3e8e-eacf-0a30-e063-6294a90ab7ec2025-10-29WarningsExact identifier
application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
application number: M020
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact identifier
application number: M020
KidsBliss Baby and Kids Mineral Sunscreen SPF50ZINC OXIDEVeganicSKN2dfa236f-128b-17bb-e063-6294a90aa29c2025-10-24WarningsExact identifier
application number: M020
Oze Sun Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd7477-445f-d1d5-e063-6394a90a46072025-10-24WarningsExact identifier
application number: M020
Oze Sun reef safe Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41dd936b-0ea6-03a2-e063-6394a90a4fba2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 yearsZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de1cd7-fdfd-7f7a-e063-6394a90a9b5c2025-10-24WarningsExact identifier
application number: M020
Soodox Natural Mineral Sunscreen SPF50 - 7 years to adultZINC OXIDE SUNSCREENVEGANIC SKN LIMITED41de09dc-544f-9780-e063-6394a90acd272025-10-24WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC23670a30-6619-0651-e063-6394a90af9782025-10-24WarningsExact identifier
application number: M020
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
application number: M020
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENECHOP SAVER FRESH CITRUS SPF 15 LIP BALMGood for the Goose Products, LLC2786cec8-0b8e-9c83-e063-6394a90ab3382025-10-23WarningsExact identifier
application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30ZINC OXIDEThrive Natural Care, Inc128e1a3a-df40-f51c-e063-6394a90a19022025-10-23WarningsExact identifier
application number: M020
Thrive Bodyshield 50 SPF 50ZINC OXIDEThrive Natural Care, Inc12d9e1d0-c59c-f770-e063-6294a90a81912025-10-23WarningsExact identifier
application number: M020
Good Defense Daily Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEOffspring Beauty Co.2a462e60-6353-f791-e063-6294a90a62e32025-10-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-124-015762701240130 mL in 1 BOTTLE30 mlHistorical
57627-124-02576270124021 BOTTLE in 1 CARTON (57627-124-02) / 30 mL in 1 BOTTLE (57627-124-01) 1 bottle2012-08-220000-00-00NoNoCurrent