Mark Glossworks Lip Gloss (Octinoxate, Avobenzone, Octisalate) Lipstick [Avon Products, Inc] -

MARK GLOSSWORKS LIP GLOSS (OCTINOXATE, AVOBENZONE, OCTISALATE) LIPSTICK [AVON PRODUCTS, INC]
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NDC	10096-0298-1, 10096-0298-2
Set ID	58626b79-60fd-4a75-be8a-4461a881ebf6
Category	HUMAN OTC DRUG LABEL
Packager	Avon Products, Inc
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

Active ingredient
Octinoxate 1.0%................................

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

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

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

.................................Sunscreen

.................................Sunscreen
INDICATIONS & USAGE

Uses
• helps prevent sunburn
WARNINGS

Warnings
For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION

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

Other information

• protect the product in this container from excessive heat and direct sun
INACTIVE INGREDIENT

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
QUESTIONS

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

INGREDIENTS AND APPEARANCE

MARK GLOSSWORKS LIP GLOSS
octinoxate, avobenzone, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10096-0298
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg in 1 g

#	Item Code	Package Description
Packaging
1	NDC:10096-0298-2	1 in 1 CARTON
1	NDC:10096-0298-1	3 g in 1 VIAL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/29/2013

Labeler - Avon Products, Inc (001468693)

Name	Address	ID/FEI	Business Operations
Establishment
Intercos America, Inc		883457061	manufacture(10096-0298)

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Medic

MARK GLOSSWORKS LIP GLOSS (OCTINOXATE, AVOBENZONE, OCTISALATE) LIPSTICK [AVON PRODUCTS, INC]

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