FDA.reportPublic FDA data

Anew Vitale Day Lotion Broad Spectrum SPF 25

Manufacturer
New Avon LLC
Effective date
2019-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:59:12

Label at a glance#

ProductAnew Vitale Day
Active ingredientHOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE
Label structure8 sections

Storage and handling

Other Information protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Homosalate 8.0%............................
Octinoxate 5.0%..............................
Oxybenzone 4.0%.........................
Avobenzone 2.85%...........................

OTC - PURPOSE SECTION

Purpose
............... Sunscreen
............... Sunscreen
.............. Sunscreen

.............. Sunscreen

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

​For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 month of age:ask a doctor
  • 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 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

STORAGE AND HANDLING SECTION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients:
water/eau, butylene glycol, dimethicone, PEG-8, trisiloxane, glycerin, ethylhexyl isononanoate, HDI/trimethylol hexyllactone crosspolymer,
cetyl alcohol, caprylyl glycol, behenyl alcohol, dilauryl thiodipropionate, thiodipropionic acid, carbomer, glyceryl stearate, parfum/fragrance,
sodium hydroxide, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl acrylate crosspolymer, disodium
EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol, ceteth-24, panthenol, silica, mesyloxybenzyl methoxyethyl chlorobenzamide,
pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10.

OTC - QUESTIONS SECTION

Questions?
1-800-FOR-AVON or 1-800-265-AVON in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDPimage of cartonimage of cartonimage of cartonimage of cartonimage of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0322-22021-01-29C16284748780-1ba0f9c33-4437-a910-e053-dadaa90a0b85Anew Vitale Day Lotion Broad Spectrum SPF 25
10096-0322-42021-01-29C16284748780-1ba0f9c33-4437-a910-e053-dadaa90a0b85Anew Vitale Day Lotion Broad Spectrum SPF 25
10096-0322-52021-01-29C16284748780-1ba0f9c33-4437-a910-e053-dadaa90a0b85Anew Vitale Day Lotion Broad Spectrum SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0322-1Anew VitaleDay50 mL in 1 JARLOTION504
10096-0322-2Anew VitaleDay1 in 1 CARTONLOTION14
10096-0322-3Anew VitaleDay15 mL in 1 JARLOTION154
10096-0322-4Anew VitaleDay1 in 1 CARTONLOTION14
10096-0322-5Anew VitaleDay1.1 mL in 1 PACKETLOTION1.14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0322ANEW VITALE DAY (HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE) LOTION [NEW AVON LLC]4Legacy NDC, 5 package rows20190416_7ba1d4aa-e976-4fa8-bce9-56a1642d762a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-032210096-0322-1, 10096-0322-2, 10096-0322-3, 10096-0322-4, 10096-0322-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB

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
8695f02f-d982-51fc-e053-2991aa0a9eb77ba1d4aa-e976-4fa8-bce9-56a1642d762a2019-01-01WarningsExact identifier
spl id: 8695f02f-d982-51fc-e053-2991aa0a9eb7
spl set id: 7ba1d4aa-e976-4fa8-bce9-56a1642d762a

Reported adverse events (FAERS/openFDA)#

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