FDA.reportPublic FDA data

Clearskin Professional

Manufacturer
New Avon LLC | Avon Products, Inc.
Effective date
2016-02-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:45:19

Label at a glance#

ProductClearskin Professional Oil Free
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 Ingredient
OCTINOXATE 7.11%, OCTISALATE 4.5%,
OXYBENZONE 3.0%, AVOBENZONE 2.5%.......

SPL UNCLASSIFIED SECTION

Purpose

.....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 generously and evenly 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,PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERYL STEARATE, THIODIPROPIONIC ACID, RETINYL PALMITATE, TRITICUM VULGARE (WHEAT) GERM EXTRACT, SACCHAROMYCES/ZINC FERMENT, GLYCOLIC ACID, SALICYLIC ACID, PYRIDOXINE HCL,TOCOPHEROL, PALMITOYL OLIGOPEPTIDE,PALMITOYL TETRAPEPTIDE- 7, GLYCERIN, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA, ISOHEXADECANE, ACRYLATES CROSSPOLYMER, PEG-100 STEARATE, CAPRYLYL GLYCOL, HYDROGENATED POLYISOBUTENE, HYDROXYETHYLCELLULOSE, XANTHAN GUM, CHOLETH-24, POLYSORBATE 60, CETETH-24, ISODODECANE, SORBITAN ISOSTEARATE, POLYSTYRENE/HYDROGENATED POLYISOPENTENE COPOLYMER, BUTYLENE GLYCOL, CARBOMER, POLYSORBATE 20, STEARETH-2, AMMONIUM HYDROXIDE, CETYL ALCOHOL, STEARIC ACID, DISODIUM EDTA, PHENOXYETHANOL, PARFUM/FRAGRANCE.

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-800-FOR-AVON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0185-22020-01-31C16284748780-19d75b9d0-5ec0-f424-e053-dadaa90a57cefae9321e-a65d-4ed5-9c33-fca47b05f7a2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0185-1Clearskin ProfessionalOil Free75 mL in 1 TUBELOTION753
10096-0185-2Clearskin ProfessionalOil Free1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0185CLEARSKIN PROFESSIONAL OIL FREE (OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) LOTION [NEW AVON LLC]3Legacy NDC, 2 package rows20160303_fae9321e-a65d-4ed5-9c33-fca47b05f7a2.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 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-018510096-0185-1, 10096-0185-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
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
322f9e62-5cec-4e4e-b97a-73f80e891cd8fae9321e-a65d-4ed5-9c33-fca47b05f7a22016-02-11WarningsExact identifier
spl id: 322f9e62-5cec-4e4e-b97a-73f80e891cd8
spl set id: fae9321e-a65d-4ed5-9c33-fca47b05f7a2

Reported adverse events (FAERS/openFDA)#

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