FDA.reportPublic FDA data

SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30

Product NDC
53755-101
11-digit product format
537550101
Labeler code
53755
Product ID
53755-101_0c5b602d-b968-ffad-e063-6294a90a4eee
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Flageoli Limited
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
Substance
AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
30; 27; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
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
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTOCRYLENE27 mg/mL
OCTINOXATE75 mg/mL
OCTISALATE50 mg/mL
OXYBENZONE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal 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
4d11cc46-3942-1561-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53755-101-04SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30120 mL in 1 TUBECREAM1204
53755-101-04SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 301 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53755-101SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FLAGEOLI LIMITED]4Current NDC, Legacy NDC, 2 package rows20231213_4d11cc46-3942-1561-e054-00144ff8d46c.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 303 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Florida Squeezed SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFlorida Squeezed13696dc6-ae64-4760-e063-6394a90ac1922024-03-11WarningsExact identifier
application number: M020
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral Moisture Universal TintZINC OXIDESPF Ventures, LLC12d27da2-2689-496a-e063-6294a90aaa9f2024-03-08WarningsExact identifier
application number: M020
Avene Multi-Defense FluidZINC OXIDEPierre Fabre USA Inc.1329e56d-1e74-4bcc-e063-6394a90ae0c32024-03-08WarningsExact identifier
application number: M020
Avene Multi-Defense Fluid TintedZINC OXIDEPierre Fabre USA Inc.132bdf9a-c5d0-e7e5-e063-6394a90a61802024-03-08WarningsExact identifier
application number: M020
Avene Face Sunscreen SPF 50ZINC OXIDEPierre Fabre USA Inc.132ce436-a783-2ba0-e063-6394a90a4b702024-03-08WarningsExact identifier
application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar SparkleHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLCcfd1e0c7-7e4c-41c1-8788-b73f83bf38c92024-03-06WarningsExact identifier
application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance FreeHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLC658b1b20-6540-4f3a-ac9a-170bc8fcba112024-03-06WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 15 EQBAVOBENZONE 3% OCTOCRYLENE 10%Walmarta0c452a9-3e99-41b8-b9b2-c1b57b66f1832024-03-06WarningsExact identifier
application number: M020
Target Up and Up Sport SPF 50AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb81b2e7e-6d7f-fa1d-e053-2995a90a7d152024-03-06WarningsExact identifier
application number: M020
Target Up and Up Reef Conscious Formula SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONb5fd43ee-9fa1-13c1-e053-2995a90a364a2024-03-06WarningsExact identifier
application number: M020
Vacation SPF 30 Baby OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f6030311-5287-3aa3-e053-2995a90a1b872024-03-06WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
application number: M020
Dermachange SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPrivate Label Beauty and Wellness12f00cee-dd9b-19b1-e063-6294a90adccb2024-03-05WarningsExact identifier
application number: M020
Brush On Block Quick Stick SPF 40 Mineral StickZINC OXIDESPF Ventures LLC12d10ec9-847a-7483-e063-6294a90a42a72024-03-04WarningsExact identifier
application number: M020
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc OxideZINC OXIDELucin Organics, LLCd717dda8-60bb-40a0-86f9-6d724d695d162024-03-04WarningsExact identifier
application number: M020
Brush On Block Bounce Butter SPF 30 Moisturizing MousseZINC OXIDESPF Ventures LLC12956754-b4e5-0203-e063-6294a90a2b962024-03-01WarningsExact identifier
application number: M020
Derma E Sun Protection Mineral SPF 30ZINC OXIDEderma ebb8e3df2-23e8-4ad0-a662-ff02d156e7b12024-02-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53755-101-04537550101041 TUBE in 1 BOX (53755-101-04) / 120 mL in 1 TUBE1 tube2021-07-012022-05-06NoNoCurrent