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 93 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08134b95-1879-27e5-e063-6294a90a29af2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incded1f158-36d1-153f-e053-2995a90ace302025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08147940-0e8b-c894-e063-6394a90af8ac2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince468d703-fa6c-095a-e053-2a95a90a51942025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPL 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incdf4b522e-93d4-1284-e053-2a95a90a1cd92025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a40ff-a014-3995-e063-6394a90a11e62025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Ince451ecfb-cf17-c622-e053-2a95a90a4d4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact identifier
application number: M020
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incf41e09bf-407d-65a4-e053-2a95a90a24362025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Hydragel SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdort Incb5f7cacb-92b9-a6b7-e053-2a95a90aea022025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd6112fe-89e4-a79b-e053-2a95a90ad7f42025-12-31WarningsExact identifier
application number: M020
Eucerin Age Defense SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdort Inccd9d4f30-fb37-9935-e053-2995a90a99362025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Inccc5d1f9b-2c8a-1392-e053-2a95a90acb9e2025-12-31WarningsExact identifier
application number: M020
Coppertone Every Tone Brightening Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc23e368db-4b2f-d23b-e063-6394a90a1f062025-12-31WarningsExact 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