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Avon Products, Inc.




FULL PRESCRIBING INFORMATION

Uses

USES: HELPS PREVENT SUNBURN. HIGHER SPF GIVES MORE SUNBURN PROTECTION.

DIRECTIONS: APPLY IN THE MORNING. PAT ON EYELIDS AND UNDER EYES. APPLY EVENLY BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER TOWEL DRYING, SWIMMING, OR PERSPIRING. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.

WARNINGS: FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Active ingredient

    ACTIVE INGREDIENTS:
     OCTINOXATE 7.5%    
     OXYBENZONE 3.0%
     OCTISALATE 3.0%
     AVOBENZONE 2.0%

INACTIVE INGREDIENTS:

     WATER/EAU
     GLYCERIN
     DIMETHICONE
     SILICA
     ARISTOTELIA CHILENSIS FRUIT JUICE
     GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
     MEDICAGO SATIVA (ALFALFA) EXTRACT
     CARBOMER
     BENZYL ALCOHOL
     PEG-40 STEARATE
     STEARETH-2
     GLYCERYL STEARATE
     HYDROGENATED POLYDECENE
     PENTYLENE GLYCOL
     DIMETHICONE CROSSPOLYMER
     METHYLPARABEN
     SODIUM HYDROXIDE
     TETRASODIUM EDTA
     RIBES NIGRUM (BLACK CURRANT) BUD WAX
     CITRUS AURANTIUM DULCIS (ORANGE) FLOWER WATER
     PROPYLPARABEN
     ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
     ASCORBYL PALMITATE
     PHYTOL
     RETINYL PALMITATE
     GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
     SODIUM HYALURONATE
     PHOSPHORIC ACID
     TOCOPHEROL


mark.

mark.

Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10096-0255
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 1.125 mL
OXYBENZONE OXYBENZONE 0.45 mL
OCTISALATE OCTISALATE 0.45 mL
AVOBENZONE AVOBENZONE 0.3 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10096-0255-1 15 in 1 BOTTLE, PUMP
2 NDC:10096-0255-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-04-14


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