FDA.reportPublic FDA data

Cancer Council Daily Body Moisturizer SPF50 Plus

Manufacturer
Vitality US Co.
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:43

Label at a glance#

ProductCancer Council Daily Body Moisturizer 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: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 measu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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, Beeswax, Cyclomethicone, Isopropyl Palmitate, Cetearyl Alcohol, Ceteareth-20, Carbomer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Triethanolamine, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric Acid

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84258-001-01Cancer Council Daily Body Moisturizer SPF50 Plus148 mL in 1 TUBELOTION1481
84258-001-01Cancer Council Daily Body Moisturizer SPF50 Plus1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84258-001CANCER COUNCIL DAILY BODY MOISTURIZER SPF50 PLUS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [VITALITY US CO.]1Current NDC, 2 package rows20240920_16296d3e-286a-e015-e063-6394a90a4189.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84258-00184258-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
YELLOW WAX2ZA36H0S2VIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TROLAMINE9O3K93S3TKIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
OCTISALATE4X49Y0596WACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
AVOBENZONEG63QQF2NOXACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
BENZYL ALCOHOLLKG8494WBHIACT
MALTODEXTRIN7CVR7L4A2DIACT

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 Daily Body Moisturizer SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16296d3e-286a-e015-e063-6394a90a41892024-04-15WarningsExact identifier
ndc (package): 84258-001-01
ndc (product): 84258-001
ndc11 (package): 84258000101
spl id: 16295213-541f-d808-e063-6394a90a517f
spl set id: 16296d3e-286a-e015-e063-6394a90a4189

Reported adverse events (FAERS/openFDA)#

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