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Avon Products, Inc.




FULL PRESCRIBING INFORMATION

Active ingredient

​Active Ingredients

​Homosalate 8.0%.........

Octinoxate 7.5%...........

Octisalate 5.0%............

Oxybenzone 5.0%..........

Avobenzone 3.0%..........

Purpose

​ Purpose

​...........Sunscreen

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

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

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

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

Uses

​Uses

  • ​helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun

​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:​ Water/Eau, Butylene Glycol, Glycerin, PEG-8, Dimethicone, Nylon-12, Citrus Medica Limonum (Lemon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Fumaria Officinalis Flower/Leaf/Stem Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Vanilla Planifolia Fruit Extract, Theobroma Cacao (Cocoa) Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Vitis Vinifera (Grape) Fruit Extract, Tromethamine, Silica, Trimethylsiloxysilicate, Glyceryl Stearate, Hydrogenated Lecithin, Carbomer, Polyglyceryl-3 Diisostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Fumaric Acid, Citric Acid, Disodium EDTA, Benzyl Alcohol, Cetyl Alcohol, Polysorbate 60, Methylparaben, Propylparaben

​Questions or Comments? ​Call toll free ​1-800-meetmark

mark. For Gooness Face mark. For Gooness Face mark. For Gooness Face

mark. For Gooness Face

Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10096-0144
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HOMOSALATE Homosalate 80 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 50 mg
OXYBENZONE OXYBENZONE 50 mg
AVOBENZONE AVOBENZONE 30 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10096-0144-1 50 in 1 JAR
2 NDC:10096-0144-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-03-08


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