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Avon Products, Inc




FULL PRESCRIBING INFORMATION

Active ingredient

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

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

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

Purpose

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


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


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

Uses

Uses
• helps prevent sunburn

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.

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

Other information

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

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

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Octinoxate, Avobenzone, Octisalate LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10096-0298
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 10 mg
AVOBENZONE AVOBENZONE 5 mg
OCTISALATE OCTISALATE 5 mg

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-03-29


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