MARK GLOSSWORKS LIP GLOSS- octinoxate, avobenzone, octisalate lipstick

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Drug Labeling and Warnings

mark by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc, Intercos America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

Labeler - Avon Products, Inc (001468693)

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