FDA.reportPublic FDA data

Flawless Effect Liquid Foundation SPF 15

Product NDC
57627-113
11-digit product format
576270113
Labeler code
57627
Product ID
57627-113_5da9858b-49e3-023c-e063-6294a90a6d18
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-25
Substance
OXYBENZONE; OCTINOXATE
Active strength
.9; 2.25 g/30g; g/30g
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
Flawless Effect Liquid Foundation SPF 15
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE.9 g/30g
OCTINOXATE2.25 g/30g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-113-01Flawless Effect Liquid Foundation SPF 15Merle Norman30 g in 1 BOTTLELIQUID3019
57627-113-02Flawless Effect Liquid Foundation SPF 15Merle Norman1 in 1 CARTONLIQUID119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OCTINOXATEACTIVE MOIETY4Y5P7MUD51FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OXYBENZONEACTIVE MOIETY95OOS7VE0YFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
DISODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT45ASM2L11MFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GINKGOINACTIVE INGREDIENT19FUJ2C58TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERYL 1-OLEATEINACTIVE INGREDIENTD3AEF6S35PFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
MICAINACTIVE INGREDIENTV8A1AW0880FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FOFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-113FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]18Current NDC, Legacy NDC, 2 package rows20241004_05615352-186b-4610-a719-16fc36e09bb3.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 82 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratories9983563c-1e63-0748-e053-2a95a90a971e2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact identifier
application number: M020
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-113-015762701130130 g in 1 BOTTLE30 gHistorical
57627-113-02576270113021 BOTTLE in 1 CARTON (57627-113-02) / 30 g in 1 BOTTLE (57627-113-01) 1 bottle2011-04-250000-00-00NoNoCurrent