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 334 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1OCTINOXATE, OXYBENZONEAmway Corpd810bbe7-a889-4737-9a78-d996fec711222023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1OCTINOXATE, OXYBENZONEAmway Corp0039ca4d-2a0c-4b19-a029-1c080fc292ce2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1OCTINOXATE, OXYBENZONEAmway Corp410592f1-57f5-4c17-8162-a0c088f0bf272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1OCTINOXATE, OXYBENZONEAmway Corpe4e61943-ec96-467c-8921-ee531ef4f13d2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1OCTINOXATE, OXYBENZONEAmway Corp62ff0eea-b67e-476c-b7f2-0fcaed9dc2272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1OCTINOXATE, OXYBENZONEAmway Corp179e5268-8eca-40b7-aa7f-ede221fa9c892023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1OCTINOXATE, OXYBENZONEAmway Corp8a3fcfaa-5bfa-4f77-932f-bfb75628c9c62023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1OCTINOXATE, OXYBENZONEAmway Corp18c11289-9cc0-4a37-a299-ee3c358dbeca2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1OCTINOXATE, OXYBENZONEAmway Corpd7cb8e53-a36f-43d1-9918-f5680aafb2c42023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2OCTINOXATE, OXYBENZONEAmway Corp01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f52023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1OCTINOXATE, OXYBENZONEAmway Corpff9c6565-a942-494f-af8c-557974675db82023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1OCTINOXATE, OXYBENZONEAmway Corp9ca531ae-10b5-4791-b62c-37b99bc1d4ea2023-10-23WarningsExact identifier
application number: M020
g and h Protect BodyENSULIZOLE, OCTISALATE, ZINC OXIDEAccess Business Group LLC03768ff4-0c67-48b3-a2f3-321d0a6790e82023-10-23WarningsExact identifier
application number: M020
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
application number: M020
Coconut SPF 15 Broad Spectrum Lip BalmCOCONUT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d28eb-2f41-7146-e053-2a95a90a86722023-10-23WarningsExact identifier
application number: M020
Bubblegum SPF 15 Broad Spectrum Lip BalmBUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7590383-661f-5b1e-e053-2995a90a197e2023-10-23WarningsExact identifier
application number: M020
Blackberry Smoothie SPF 15 Broad Spectrum Lip BalmBLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7577d5f-69d8-3f32-e053-2995a90aaba52023-10-23WarningsExact identifier
application number: M020
Breath Fresh SPF 15 Broad Spectrum Lip BalmBREATH FRESH SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c3a62f-5c11-c78c-e053-2a95a90a3a582023-10-23WarningsExact 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