mark

Manufacturer
Avon Products, Inc | Intercos America, Inc
Effective date
2013-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:07

Label at a glance#

Productmark Glossworks Lip Gloss
Active ingredientOCTINOXATE, AVOBENZONE, OCTISALATE
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 1.0%................................

Avobenzone 0.5%................................

Octisalate 0.5%................................

OTC - PURPOSE SECTION

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


.................................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:
ETHYLHEXYL ISONONANOATE, HYDROGENATED STYRENE/BUTADIENE COPOLYMER, HYDROGENATED POLYISOBUTENE, SILICA SILYLATE,  CAPRYLIC/CAPRIC TRIGLYCERIDE, DICALCIUM PHOSPHATE, PARFUM/FRAGRANCE, STEARALKONIUM HECTORITE, PROPYLENE CARBONATE,
SILICA, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE SPARKLE SHADES MAY ALSO CONTAIN: TIN OXIDE, CALCIUM ALUMINUM BOROSILICATE MAY CONTAIN: MICA/CI 77019, TITANIUM DIOXIDE/CI 7789, IRON OXIDES, RED 7 LAKE/CI 15850, RED 30 LAKE/CI 73360, YELLOW 5 LAKE/CI 19140, BLUE 1 LAKE/CI 42090

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 DFBimage of DFBimage of DFBimage of DFBiimage of DFBiimage of DFBimage of DFBimage of DFB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0298-22020-01-31C16284748780-19d75b9d0-df72-f424-e053-dadaa90a57ce58626b79-60fd-4a75-be8a-4461a881ebf6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0298-1markGlossworks Lip Gloss3 g in 1 VIALLIPSTICK31
10096-0298-2markGlossworks Lip Gloss1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0298MARK GLOSSWORKS LIP GLOSS (OCTINOXATE, AVOBENZONE, OCTISALATE) LIPSTICK [AVON PRODUCTS, INC]1Legacy NDC, 2 package rows20130407_58626b79-60fd-4a75-be8a-4461a881ebf6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-029810096-0298-1, 10096-0298-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB

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
d43b3c91-84e0-44a0-9b88-03e38256b25658626b79-60fd-4a75-be8a-4461a881ebf62013-03-29WarningsExact identifier
spl id: d43b3c91-84e0-44a0-9b88-03e38256b256
spl set id: 58626b79-60fd-4a75-be8a-4461a881ebf6

Reported adverse events (FAERS/openFDA)#

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