AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE

Manufacturer
Flageoli Limited
Effective date
2023-12-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:38

Label at a glance#

ProductSERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER ...
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%
Octocrylene 2.7%
Octinoxate 7.5%
Octisalate 5%
Oxybenzone 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, dimethicone, potassium cetyl phosphate, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, tocopherol, anogeissus leiocarpus bark extract, mandarin orange (citrus nobilis) peel extract, lemon (citrus medica limonum) fruit extract, acerola (malpighia glabra) fruit extract, hydrolyzed collagen, maltodextrin, urea, alpha-glucan oligosaccharide, creatine, lime (citrus aurantifolia) fruit extract, lactic acid, ascorbic acid, hydroxyapatite, glutathione, cysteine, hydrolyzed vegetable protein, passiflora incarnata extract, hydroxyethylcellulose, magnesium aluminum silicate, sodium ascorbyl phosphate, caprylyl glycol, sodium citrate, sodium polyacrylate, disodium edta, propanediol, propylene glycol butylene glycol, lecithin, hydroxyphenyl propamidobenzoic acid, ascorbyl palmitate, tetrahexyldecyl ascorbate, 3-o-ethyl ascorbic acid, magnesium ascorbyl phosphate, potassium ascorbyl tocopheryl phosphate, magnesium aspartate, zinc gluconate, ethoxydiglycol, zeolite, silica, sodium chloride, tetrasodium glutamate diacetate, calcium gluconate, copper gluconate, acetyl tetrapeptide-17 (and) colloidal platinum, ethylhexylglycerin, citric acid, fragrance (parfum), phenoxyethanol, sodium hydroxymethylglycinate, sodium benzoate, potassium sorbate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelTubeTube

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53755-100-60SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 301 in 1 BOXCREAM15
53755-100-60SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 3060 mL in 1 TUBECREAM605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53755-100SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FLAGEOLI LIMITED]5Current NDC, Legacy NDC, 2 package rows20231208_4833b0b1-33b7-59d4-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53755-10053755-100-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4833b0b1-33b7-59d4-e054-00144ff8d46c2023-12-07WarningsExact identifier
ndc (package): 53755-100-60
ndc (product): 53755-100
ndc11 (package): 53755010060
spl id: 0be8bf72-ed3d-549e-e063-6294a90a64fe
spl set id: 4833b0b1-33b7-59d4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.