FDA.reportPublic FDA data

Cancer Council Invisible Fluid SPF50 Plus

Manufacturer
Vitality US Co.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:13

Label at a glance#

ProductCancer Council Invisible Fluid SPF50 Plus
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure9 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 15 minutes before sun exposure apply to all skin exposed to the sun reapply at least every 2 hours use a water resistance 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 of 15 or higher and other sun protection measures including: ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply at least every 2 hours
  • use a water resistance 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cocoglycerides, Silica, Cetyl Dimethicone, PEG-15 Cocamine, Stearyl Behenate, Glycerin, PEG-40 Stearate, C12-15 Alkyl Benzoate, Polyhydroxystearic Acid, Tocopheryl Acetate, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Disodium EDTA, Acrylates/C10-C30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Triethanolamine, Aloe Barbadensis Leaf Juice, Pentylene Glycol, Potassium Sorbate, Sodium Benzoate

Other information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

info@vitalityusco.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84258-003-01Cancer Council Invisible Fluid SPF50 Plus50 mL in 1 TUBELOTION502
84258-003-01Cancer Council Invisible Fluid SPF50 Plus1 in 1 CARTONLOTION12

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84258-00384258-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-40 MONOSTEARATEECU18C66Q7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
STEARYL BEHENATEA68S9UI39DIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PEG-15 COCAMINE8L6LB12TSJIACT
CETYL DIMETHICONE 45IK315POC44IACT
WATER059QF0KO0RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
EDETATE DISODIUM7FLD91C86KIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TROLAMINE9O3K93S3TKIACT
OCTISALATE4X49Y0596WACTIB
PENTYLENE GLYCOL50C1307PZGIACT
AVOBENZONEG63QQF2NOXACTIB
POTASSIUM SORBATE1VPU26JZZ4IACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
COCO-GLYCERIDESISE9I7DNUGIACT
CAPRYLYL GLYCOL00YIU5438UIACT

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
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
ndc (package): 84258-003-01
ndc (product): 84258-003
ndc11 (package): 84258000301
spl id: 450ebc54-6e45-84e6-e063-6394a90a3a77
spl set id: 1629b02b-e9f3-0593-e063-6294a90a9aa5

Reported adverse events (FAERS/openFDA)#

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