Anew Vitale Day Cream Broad Spectrum SPF 25

Manufacturer
New Avon LLC
Effective date
2019-01-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:59:13

Label at a glance#

ProductAnew Vitale Day
Active ingredientOCTINOXATE, OCTISALATE, 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
Octinoxate 7.0%.................................
Octisalate 4.5%....................................
Oxybenzone 4.0%...............................
Avobenzone 2.8%..................................

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, dimethicone, glycerin, PEG-8, butyloctyl salicylate, cetearyl alcohol, trisiloxane, dilauryl thiodipropionate, phytol, behenyl alcohol,
thiodipropionic acid, panthenol, mesyloxybenzyl methoxyethyl chlorobenzamide, pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10, kaempferia galanga root extract, polysorbate 60, ceteareth-20, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dimethicone crosspolymer, isohexadecane, carbomer, sodium hydroxide, disodium EDTA, caprylyl glycol, 1,2-hexanediol, parfum/fragrance.

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 cartonimage of cartonimage of cartonimage of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0319-1Anew VitaleDay50 g in 1 JARCREAM505
10096-0319-2Anew VitaleDay1 in 1 CARTONCREAM15
10096-0319-3Anew VitaleDay15 g in 1 JARCREAM155
10096-0319-4Anew VitaleDay1 in 1 CARTONCREAM15
10096-0319-5Anew VitaleDay1.1 g in 1 PACKETCREAM1.15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0319ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [NEW AVON LLC]5Legacy NDC, 5 package rows20190416_9f8ef748-fc61-4f49-909f-93fed9c8a08a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OXYBENZONEACTIVE MOIETY95OOS7VE0Y2

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
10096-031910096-0319-1, 10096-0319-2, 10096-0319-3, 10096-0319-4, 10096-0319-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
8695e3ec-61a6-f2e4-e053-2a91aa0a15b09f8ef748-fc61-4f49-909f-93fed9c8a08a2019-01-01WarningsExact identifier
spl id: 8695e3ec-61a6-f2e4-e053-2a91aa0a15b0
spl set id: 9f8ef748-fc61-4f49-909f-93fed9c8a08a

Reported adverse events (FAERS/openFDA)#

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