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 278 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF100 SPORT Broad SpectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWAL-MART STORES INC1ce4839b-f693-4653-8fe2-444df76eb83c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50HOMOSALATE , OCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c892024-10-16WarningsExact identifier
application number: M020
EQUATE Sunscreen BABY Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INCb2083cbd-ef19-4edc-9d7d-eca3452ee0ee2024-10-16WarningsExact identifier
application number: M020
Equate-Sunscreen Broad Spectrum SPF 50 ULTRAAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWal-Mart Stores Incbbe06f23-0d0f-43ff-9d1b-37a99d9d62062024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.c8c1c904-12f5-48e0-e053-2a95a90a9f752024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEBIG LOTS STORES, INC.e717ec77-8beb-645a-e053-2a95a90ac11b2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 50 Ultra Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBIG LOTS STORES, INC.f0dcb5d8-a3e5-4334-e053-2995a90a535a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE,BIG LOTS STORES, INC.c8aede4f-3d84-63d1-e053-2a95a90afb1a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sun DefenseAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBIG LOTS STORES, INC.db3ad809-d6c9-6c83-e053-2a95a90ac58b2024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.e4b70fdb-7548-175c-e053-2995a90adfe62024-10-16WarningsExact identifier
application number: M020
BIOLUMIN-C HEAT AGING PROTECTOR SPF50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.38d0b78b-bd8e-4cb0-925a-19adff550c192024-10-16WarningsExact identifier
application number: M020
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact 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