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Name:Anew Solar Advancesunscreen Body Mist
Manufacturer:Avon Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ANEW SOLAR ADVANCE SUNSCREEN BODY MIST - homosalate , octinoxate , octisalate , oxybenzone , avobenzone and octocrylene  spray 
Avon Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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To Use: Apply liberally and evenly 15 minutes before sun
exposure. Spray evenly over skin and rub in. Reapply as
needed or after towel drying, swimming, or perspiring. Children
under 6 months of age: ask a doctor.

Warning: For external use only. When using this product, keep
out of eyes. Rinse thoroughly with water to remove. Stop use
and ask a doctor if rash or irritation develops and lasts. Keep
out of reach of children.

Uses: Helps prevent sunburn. Higher SPF gives more
sunscreen protection. Moderate sun protection product.
Retains SPF after 80 minutes of activity in the water.

Flammable, contents under pressure. Keep away from flame,
fire or extreme heat. Do not place in hot water or near
radiators, stove, or other sources of heat. Do not use in
presence of open flame or sparks. Do not store at
temperatures above 120°F.

ACTIVE INGREDIENTS/ INGREDIENTES ACTIVOS:
HOMOSALATE 8.00%, OCTINOXATE 7.5%, OCTISALATE
4.75%, OXYBENZONE 4.75%, AVOBENZONE 2.85%,
OCTOCRYLENE 2.56%.

OTHER INGREDIENTS/OTROS INGREDIENTES: SD
ALCOHOL 40-B, C12-15 ALKYL BENZOATE, PPG-2
MYRISTYL ETHER PROPIONATE, DIMETHICONE, GLYCERIN,
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER,
POLYESTER-8, DILAURYL THIODIPROPIONATE,
KAEMPFERIA GALANGA ROOT EXTRACT, GLYCINE SOJA
(SOYBEAN) SEED EXTRACT, PHAEODACTYLUM
TRICORNUTUM EXTRACT, ORYZANOL, FOENICULUM
VULGARE (FENNEL) FRUIT EXTRACT, DAUCUS CAROTA
SATIVA (CARROT) ROOT EXTRACT, TOCOPHEROL,
CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL,
PARFUM/ FRAGRANCE, WATER/EAU.

image of PDPimage of cartonimage of carton


ANEW SOLAR ADVANCE  SUNSCREEN BODY MIST
homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0254
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE ) HOMOSALATE 12 mL  in 150 mL
OCTINOXATE (OCTINOXATE ) OCTINOXATE 11.25 mL  in 150 mL
OCTISALATE (OCTISALATE ) OCTISALATE 7.125 mL  in 150 mL
OXYBENZONE (OXYBENZONE ) OXYBENZONE 7.125 mL  in 150 mL
AVOBENZONE (AVOBENZONE ) AVOBENZONE 4.275 mL  in 150 mL
OCTOCRYLENE (OCTOCRYLENE ) OCTOCRYLENE 3.84 mL  in 150 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0254-2 1 CAN ( CAN) in 1 CARTON contains a CAN (10096-0254-1)
1 NDC:10096-0254-1 150 mL in 1 CAN This package is contained within the CARTON (10096-0254-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/11/2011

Labeler - Avon Products, Inc. (001468693)

Revised: 04/2011 Avon Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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