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 42 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.6a48ad0d-20e4-44b1-90d6-30bfbc68a1522026-04-17WarningsExact identifier
application number: M020
Pacto Refreshing Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEMynd LLC56ad7c97-3dae-4bac-a677-f5052dfdfea42026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f95cd0a-f996-648b-e063-6294a90adc282026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f968058-e851-86d0-e063-6294a90aa7862026-04-16WarningsExact identifier
application number: M020
Red Cherry SPF 15 Broad Spectrum Lip BalmRED CHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc4f96d057-39b8-e4d5-e063-6394a90acb5c2026-04-16WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-LightZINC OXIDEZO Skin Health, Inc.4f9988a0-ae4a-9940-e063-6294a90ad91d2026-04-16WarningsExact identifier
application number: M020
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
application number: M020
Tanning Club Everyday Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONETANNING CLUB, LLC75820400-a5e0-4cf5-8b4f-a52500ce62c32026-04-15WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
application number: M020
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
application number: M020
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
application number: M020
PHELITYL DAY SPF 15PHELITYL DAY SPF 15PML NYC, LLCea9d33d9-6f9f-0a66-e053-2a95a90abd422026-04-15WarningsExact identifier
application number: M020
FIRMARINE MOISTURIZER SPF 30FIRMARINE MOISTURIZER SPF 30PML NYC, LLCea9db179-1b69-01e0-e053-2a95a90a16282026-04-15WarningsExact identifier
application number: M020
EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15PML NYC, LLCeaa562b1-3fc6-1a85-e053-2995a90ad1ec2026-04-15WarningsExact identifier
application number: M020
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
application number: M020
RICH GIRL HAND SPF 25RICH GIRL HANDPML NYC, LLCea8f4421-109f-41a5-e053-2a95a90a38322026-04-15WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen COLOR MATCH BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.cf33c5a1-b7c5-4c5a-9981-e4e24208cd112026-04-15WarningsExact identifier
application number: M020
JAFRA SUN Facial Sunscreen BROAD SPECTRUM SPF 50 WATER RESISTANT 40 MINUTESAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.56c124d7-0b8c-4bb9-8261-c7395353fbe02026-04-15WarningsExact 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