FDA.reportPublic FDA data

Anew Age-Transforming

Manufacturer
New Avon LLC | Avon Products, Inc
Effective date
2016-03-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:45:16

Label at a glance#

ProductAnew Age-Transforming Concealer
Active ingredientTITANIUM DIOXIDE, OCTINOXATE
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
Titanium Dioxide 6.62%.........................
Octinoxate 2.50%.................................

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Uses

  • helps prevent sunburn

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

  • apply liberally 15 minutes before sun exposure
  • children under 6 months 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, Propylene Glycol Dicaprylate/Dicaprate, Cyclopentasiloxane, Glycolic Acid, Polysorbate 60, Glycol Stearate, PPG-2 Myristyl Ether Propionate, Silica, Sorbitan Stearate, Foeniculum Vulgare (Fennel) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Vitis Vinifera (Grape) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Olea Europaea (Olive) Leaf Extract, Medicago Sativa (Alfalfa) Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Punica Granatum Extract,
Hydrolyzed Hibiscus Esculentus Extract, Portulaca Oleracea Extract, Saxifraga Sarmentosa Extract, Tilia Cordata Wood Extract, Panax Ginseng Root Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Yeast Extract/Extrait De Levure, Padina Pavonica Thallus Extract, Hydrolyzed Wheat Protein, Talc, Nylon-12, PEG-12 Dimethicone, Ammonium Hydroxide, Magnesium Aluminum Silicate, Paraffin, Xanthan Gum, Xymenynic Acid, Mannitol, Polymethyl Methacrylate, Phytol, Alumina, Glycogen, PEG-40 Hydrogenated Castor Oil, Calcium Pantothenate, Biotin, Tetrasodium EDTA, Imidazolidinyl Urea, Propylparaben, Methylparaben, Aluminum Hydroxide. May Contain: Iron Oxides, Mica, Bismuth Oxychloride, Titanium Dioxide.

OTC - QUESTIONS SECTION

Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDPimage of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0138-22020-01-31C16284748780-19d75b9d0-06ca-f424-e053-dadaa90a57ce5e98777d-cd67-4d36-95a5-709dc8b1db09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0138-1Anew Age-TransformingConcealer1.7 g in 1 VIAL, DISPENSINGCREAM1.73
10096-0138-2Anew Age-TransformingConcealer1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0138ANEW AGE-TRANSFORMING CONCEALER (TITANIUM DIOXIDE, OCTINOXATE) CREAM [NEW AVON LLC]3Legacy NDC, 2 package rows20160303_5e98777d-cd67-4d36-95a5-709dc8b1db09.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-013810096-0138-1, 10096-0138-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
a58da81d-3292-4471-b3a3-39d8a1beee5a5e98777d-cd67-4d36-95a5-709dc8b1db092016-03-01WarningsExact identifier
spl id: a58da81d-3292-4471-b3a3-39d8a1beee5a
spl set id: 5e98777d-cd67-4d36-95a5-709dc8b1db09

Reported adverse events (FAERS/openFDA)#

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