FDA.reportPublic FDA data

Ivory Perfecting Makeup Broad Spectrum SPF 25

Product NDC
57627-125
11-digit product format
576270125
Labeler code
57627
Product ID
57627-125_5da9bf62-7a92-018b-e063-6394a90a52a3
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
TITANIUM DIOXIDE; OCTINOXATE
Active strength
2.13; 2.25 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
Ivory Perfecting Makeup Broad Spectrum SPF 25
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-125-01Ivory Perfecting Makeup Broad Spectrum SPF 25Merle Norman30 mL in 1 BOTTLEEMULSION3010
57627-125-02Ivory Perfecting Makeup Broad Spectrum SPF 25Merle Norman1 in 1 CARTONEMULSION110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
OCTINOXATEACTIVE MOIETY4Y5P7MUD51IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
ISODODECANEINACTIVE INGREDIENTA8289P68Y2IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
SODIUM MYRISTOYL GLUTAMATEINACTIVE INGREDIENTAYU7QD893WIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5
WATERINACTIVE INGREDIENT059QF0KO0RIVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-125IVORY PERFECTING MAKEUP BROAD SPECTRUM SPF 25 MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]9Current NDC, Legacy NDC, 2 package rows20241006_748a9d28-8814-4394-ad7d-0d6ba868b0bc.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 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - BoldZINC OXIDEDRMTLGY52be6cdf-9ee5-6ce5-e063-6294a90a60752026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - SoftZINC OXIDEDRMTLGY52be975c-6a2a-cf21-e063-6294a90a7c1d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - GlowZINC OXIDEColorescience52bf01e8-0b4a-5985-e063-6294a90a62c02026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - SavannaZINC OXIDEColorescience52bebdba-6387-cc66-e063-6394a90aa35d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Violet HazeZINC OXIDEColorescience52befadc-636f-22bc-e063-6394a90acd182026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Pink SkyZINC OXIDEColorescience52bf204a-ce4e-6e01-e063-6394a90aa9762026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Golden HourZINC OXIDEColorescience52bf2d73-81ad-d455-e063-6294a90a917c2026-05-26WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Cherry NoirZINC OXIDEBlack Girl Sunscreen5290839a-c84b-b0ec-e063-6394a90abec72026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop French KissZINC OXIDEBlack Girl Sunscreen52909e40-1450-250f-e063-6294a90a8a902026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Red WineZINC OXIDEBlack Girl Sunscreen52910220-75f6-23d5-e063-6394a90a9ff32026-05-24WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PopsicleZINC OXIDERiversol529ba685-b4db-37fb-e063-6294a90a54be2026-05-24WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield ImpactZINC OXIDEMental Skin52856524-69d3-90ae-e063-6394a90abc852026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield InspireZINC OXIDEMental Skin52854049-ddc2-2d61-e063-6294a90aa22b2026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield IntentZINC OXIDEMental Skin52856573-d3c0-55b9-e063-6294a90a1b092026-05-23WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGuangzhou Danting Bath&Body Care Industry Co. Ltd5268de18-65dc-4253-e063-6394a90a6d4f2026-05-22WarningsExact identifier
application number: M020
Freaks of Nature Daily Defender Broad Spectrum SPF 30FREAKS OF NATURE DAILY DEFENDER BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.5252e628-9db9-110d-e063-6394a90a8e1d2026-05-21WarningsExact identifier
application number: M020
Hampton Sun SPF 30AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLCeae99a09-9d9e-459d-af96-aef95a854f942026-05-21Exact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Bronze)ZINC OXIDEColorescience9f303e48-037b-6a48-e053-2a95a90a7cf12026-05-21WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm (Berry)ZINC OXIDEColorescience9f2edb30-b3d6-23dc-e053-2995a90a03dc2026-05-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-125-015762701250130 mL in 1 BOTTLE30 mlHistorical
57627-125-02576270125021 BOTTLE in 1 CARTON (57627-125-02) / 30 mL in 1 BOTTLE (57627-125-01) 1 bottle2012-08-220000-00-00NoNoCurrent