FDA.reportPublic FDA data

Anew Vitale

Manufacturer
Avon Products, Inc. | Avon Manufacturing (Guangzhou) Ltd.
Effective date
2018-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:44

Label at a glance#

ProductAnew Vitale Day
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure7 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDPimage of DFBimage of DFB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71110-0008-12020-01-31C16284748780-19d75b9d0-524e-f424-e053-dadaa90a57ce6d954916-a1b5-1388-e053-2a91aa0a0a95

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71110-0008-1Anew VitaleDay1.1 g in 1 PACKETCREAM1.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71110-0008ANEW VITALE DAY (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) CREAM [AVON PRODUCTS, INC.]1Legacy NDC, 1 package rows20180601_6d954916-a1b5-1388-e053-2a91aa0a0a95.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71110-000871110-0008-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 60CAL22UVI4MIACT
ISOHEXADECANE918X1OUF1EIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERINPDC6A3C0OXIACT
THIODIPROPIONIC ACID3BBK323ED8IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PANTHENOLWV9CM0O67ZIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
TRISILOXANE9G1ZW13R0GIACT
DILAURYL THIODIPROPIONATEV51YH1B080IACT
PHYTOL5BC2RZ81NGIACT
MESYLOXYBENZYL METHOXYETHYL CHLOROBENZAMIDE3HB4C300XBIACT

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
59947357-a2bd-a147-e063-6394a90a462b6d954916-a1b5-1388-e053-2a91aa0a0a952026-08-21WarningsExact identifier
spl set id: 6d954916-a1b5-1388-e053-2a91aa0a0a95

Reported adverse events (FAERS/openFDA)#

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