FDA.reportPublic FDA data

Bare Perfecting Makeup

Product NDC
57627-123
11-digit product format
576270123
Labeler code
57627
Product ID
57627-123_5da9b2a2-e9d0-fa29-e063-6394a90ad663
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
Bare Perfecting Makeup
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
57627-123-01Bare Perfecting MakeupMerle Norman30 mL in 1 BOTTLEEMULSION3011
57627-123-02Bare Perfecting MakeupMerle Norman1 in 1 CARTONEMULSION111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BABARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
ISODODECANEINACTIVE INGREDIENTA8289P68Y2BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFABARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51EBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SODIUM MYRISTOYL GLUTAMATEINACTIVE INGREDIENTAYU7QD893WBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ABARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]4
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EBARE PERFECTING MAKEUP 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
57627-123BARE PERFECTING MAKEUP MERLE NORMAN (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MERLE NORMAN COSMETICS, INC]10Current NDC, Legacy NDC, 2 package rows20241101_0a506f55-ea6c-44d3-bab2-0a5875c43757.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 17 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30de8a-4d29-bbac-e063-6294a90a84d92026-06-26WarningsExact identifier
application number: M020
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
application number: M020
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30a422-b22a-ca79-e063-6294a90a19a92026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37a994-79dd-9720-e063-6294a90a7f342026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37b8d7-de72-f534-e063-6294a90aeab72026-06-26WarningsExact identifier
application number: M020
UV Daily Hydration TintedOCTISALAT AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc02e71602-13e1-43b3-9cba-a75e46cccacc2026-06-25WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6759b9f7-296a-4c06-9198-b4e824e0bdc92026-06-25WarningsExact identifier
application number: M020
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
application number: M020
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
application number: M020
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
application number: M020
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
application number: M020
Scalp and Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEOnly Balds LLC551bf10e-598c-1400-e063-6294a90a4af12026-06-25WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC551bd8d9-4ba7-194f-e063-6294a90abcf12026-06-25WarningsExact identifier
application number: M020
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
application number: M020
MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBRAND GENOME CO., Ltd.51c07375-e81d-8572-e063-6394a90ab5b02026-06-24WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC365613b6-36ec-0512-e063-6294a90a95322026-06-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-123-015762701230130 mL in 1 BOTTLE30 mlHistorical
57627-123-02576270123021 BOTTLE in 1 CARTON (57627-123-02) / 30 mL in 1 BOTTLE (57627-123-01) 1 bottle2012-08-220000-00-00NoNoCurrent