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
2026-12-31
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
2026-12-31

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 111 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
application number: M020
Moisturizing Mineral Sunscreen TintedZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b12dbc-5edc-aad1-e063-6394a90a42ea2025-12-17Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
application number: M020
Badger SPF 40 Tinted Mineral FaceZINC OXIDEW.S. Badger Company, Inc.4628c04f-b7a6-b3fe-e063-6294a90a16752025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a4d0e-8ab2-3d79-e063-6394a90a70062025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%Beiersdorf Inc0a5a42a3-6fe4-2980-e063-6394a90a54fe2025-12-17WarningsExact identifier
application number: M020
Coppertone Glow Suncreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdord Incb65c117d-f200-bb22-e053-2995a90ab71d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shadesZINC OXIDENoxell3fa58ac5-f45c-369a-e063-6294a90a46e42025-12-17WarningsExact identifier
application number: M020
Ray Defense Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements807db1ff-a64a-44e4-a786-f88cd45184332025-12-17WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements, Inc981c7b3c-d7d6-483d-bf32-10d526be5b3f2025-12-17WarningsExact identifier
application number: M020
Glow Oil SPF 50 Beach FlowerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2a46d7d2-293f-5024-e063-6294a90a31aa2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f114022-daaa-1834-e063-6394a90afd1d2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f113048-adfb-7d2a-e063-6294a90a20122025-12-17WarningsExact identifier
application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incf3d163b4-6774-4c2e-e053-2a95a90afd592025-12-17WarningsExact identifier
application number: M020
Coppertone EveryTone Face Sunscreen SPF 55AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b12f39-778c-ecee-e063-6394a90afa242025-12-17WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Fair CoolOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC462e9a4a-ef28-0e0e-e063-6394a90ab4f82025-12-17WarningsExact identifier
application number: M020
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact 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