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 11 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
application number: M020
MEDICUBE PDRN SILKY SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAPR US INC57154bec-6714-0314-e063-6294a90a4bd02026-07-20WarningsExact identifier
application number: M020
TOCOBO Double UV Defense SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON Co., Ltd.56aff65a-aa08-dc3f-e063-6294a90acac32026-07-19WarningsExact identifier
application number: M020
THE SPORTO Invisible Sport for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.46564a09-909d-bcc7-e063-6294a90a627b2026-07-17WarningsExact identifier
application number: M020
RR Sun CremeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEUndefined Incdc60b685-a7fc-47bb-ade9-44a8e3b548122026-07-17WarningsExact identifier
application number: M020
Cetaphil Tinted Daily Facial Moisturizer SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.0ef2ebae-7198-47f4-8891-d1ca3cf54d4b2026-07-16WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
application number: M020
BaseLife Pure Mineral Shield SunscreenZINC OXIDEWintech America, Inc.7f741a91-6ed8-4d08-9196-d15527d044d52026-07-15WarningsExact identifier
application number: M020
BaseLife Clear UV Defense SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWintech America, Inc.128db446-93ba-4347-bd39-66177572c6592026-07-15WarningsExact identifier
application number: M020
Biore Aqua Rich Facial Mist SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKao USA Inc.56a80a0d-b0b5-1098-e063-6294a90a52702026-07-15WarningsExact identifier
application number: M020
Anti Aging Lip Balm Pot SPF 15LIP BALMEpicuren Disocovery4097e28a-ed11-e16a-e063-6294a90a5e9b2026-07-14WarningsExact identifier
application number: M020
HolyCow Mineral Tallow Sunscreen Face and Body SPF 50ZINC OXIDECALM ENTERPRISE LLC722462d8-d2ab-44ce-9065-673ab20762692026-07-14WarningsExact identifier
application number: M020
X-Treme Cream Propolis Sunscreen SPF 45X-TREME CREAMEpicuren Discovery3b29976e-eee0-b978-e063-6294a90accd62026-07-14WarningsExact identifier
application number: M020
Anti-Aging Lip Balm SPF 15LIP BALMEpicuren Discovery3cbd0550-b6e5-3e86-e063-6394a90ac07f2026-07-14WarningsExact identifier
application number: M020
Zinc Oxide Perfecting SunscreenZINC OXIDEEpicuren Discovery1a0228f9-bf3f-a1fe-e063-6294a90a3fb52026-07-14WarningsExact identifier
application number: M020
Vacation FaceAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.14b8a3cf-031c-4c52-ba81-e683e69d0f372026-07-14WarningsExact identifier
application number: M020
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEL. Perrigo Companybd5c9df7-8dfb-4d20-9966-e148c5667b222026-07-14WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC4081a4ad-b738-5fb6-e063-6394a90a91712026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc5c1d8-91f8-8ad2-e063-6294a90a92292026-07-13WarningsExact identifier
application number: M020
Olay Super Serum Body Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company5513c5e2-3baf-2f09-e063-6394a90a495a2026-07-13WarningsExact 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