FDA.reportPublic FDA data

Timeless Illuminating Makeup SPF 30 Sandy Beige

Product NDC
57627-182
11-digit product format
576270182
Labeler code
57627
Product ID
57627-182_5dabb08b-1c0c-b173-e063-6294a90a7e8a
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-24
Substance
OCTINOXATE; OXYBENZONE
Active strength
7.5; 2 g/100mL; g/100mL
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
Timeless Illuminating Makeup SPF 30 Sandy Beige
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
OXYBENZONE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2406806e-f5ff-4c54-bf33-a96afaea1cccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-182-01Timeless Illuminating Makeup SPF 30 Sandy BeigeMerle Norman30 mL in 1 BOTTLECREAM304
57627-182-02Timeless Illuminating Makeup SPF 30 Sandy BeigeMerle Norman1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-182TIMELESS ILLUMINATING MAKEUP SPF 30 SANDY BEIGE MERLE NORMAN (OCTINOXATE, OXYBENZONE) CREAM [MERLE NORMAN COSMETICS, INC]3Current NDC, Legacy NDC, 2 package rows20241010_2406806e-f5ff-4c54-bf33-a96afaea1ccc.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 290 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clarity Rx Pucker Power lip plumper SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONETopiderm, Inc.92504982-fe0e-404d-b7cf-f6b340b898022024-07-31WarningsExact identifier
application number: M020
Essential Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.2132dc18-85ee-4449-86d2-d9f698f286c62024-07-31WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
application number: M020
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
application number: M020
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATEDr Pawpaw Limitedf2628e3e-9eb0-49cb-91a6-d15c48cb8a192024-07-25WarningsExact identifier
application number: M020
Thinksport Daily Face SPF 50ZINC OXIDEthinkOperations,LLCb2422785-bd35-4248-a68f-fb4b1492a4cd2024-07-24WarningsExact identifier
application number: M020
Thinkbaby Clear Zinc SPF 30ZINC OXIDEthinkOperations,LLC7cd9c971-5556-42dc-af7b-3a88221b8c942024-07-24WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.0f072099-d57d-4dc4-e063-6394a90ab4382024-07-23WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.14b11b42-d1fe-572f-e063-6394a90a9eec2024-07-23WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.e64c8644-7af4-7b7f-e053-2995a90af7112024-07-22WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC2cecda56-4860-4d35-abc2-2bb9bdf35eae2024-07-19WarningsExact identifier
application number: M020
CVS Health SPORT SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENECVS PHARMACYf0e8c724-b377-5dc0-e053-2995a90a0d542024-07-18WarningsExact identifier
application number: M020
EQUATE Sunscreen SPORT Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INC4d819fd3-de12-4394-82f4-a48faf0b70922024-07-18WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Ultra Sport SunscreenAVOBENZONE HOMOSALATE OCTOCRYLENEBIG LOTS STORES, INC.f0e82a9f-17ac-b1c5-e053-2995a90ae07a2024-07-18WarningsExact identifier
application number: M020
Equaline SPORT Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0e8dfd4-a77c-6384-e053-2a95a90a1e4a2024-07-18WarningsExact identifier
application number: M020
TopCare Everyday SPORT Sun Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETOPCO ASSOCIATES LLCf0e93aa8-1b09-1312-e053-2a95a90a79342024-07-18WarningsExact identifier
application number: M020
Safeway Signature Sport Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENESafeway, Inc.f557a3e2-e415-1b65-e053-2995a90a987a2024-07-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen Sport Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETARGET CORPORATIONbad60bc1-cf78-7a33-e053-2995a90afdc32024-07-18WarningsExact identifier
application number: M020
Scar Gel SPF 35ZINC OXIDEderma e8cd263aa-a54b-4c55-b3e2-6f6763987d4a2024-07-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-182-015762701820130 mL in 1 BOTTLE30 mlHistorical
57627-182-02576270182021 BOTTLE in 1 CARTON (57627-182-02) / 30 mL in 1 BOTTLE (57627-182-01) 1 bottle2017-01-240000-00-00NoNoCurrent