ANEW SOLAR ADVANCE SUNSCREEN BODY - homosalate , octisalate , oxybenzone , avobenzone and octocrylene  lotion 
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.
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. May stain fabrics.

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

ACTIVE INGREDIENTS/ INGREDIENTES ACTIVOS: HOMOSALATE
8.00%, OCTISALATE 4.75%, OXYBENZONE 4.75%, AVOBENZONE
2.80%, OCTOCRYLENE 2.50%.

OTHER INGREDIENTS/OTROS INGREDIENTES: WATER/EAU,
ISODODECANE, BARIUM SULFATE, PROPANEDIOL, CETYL
DIMETHICONE, SILICA, STYRENE/ ACRYLATES COPOLYMER,
ALUMINUM STARCH OCTENYLSUCCINATE, HYDROXYETHYL
UREA, CHOLETH-24, DILAURYL THIODIPROPIONATE, KAEMPFERIA
GALANGA ROOT EXTRACT, GLYCINE SOJA (SOYBEAN) SEED
EXTRACT, ORYZANOL, PHAEODACTYLUM TRICORNUTUM
EXTRACT, FOENICULUM VULGARE (FENNEL) FRUIT EXTRACT,
DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT,
TOCOPHEROL, DIMETHICONE CROSSPOLYMER, UREA, GLYCERIN,
CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL PEG/PPG-10/1
DIMETHICONE, HYDROXYETHYL ACRYLATE/ SODIUM
ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETETH-24,
PHENOXYETHANOL, ISOHEXADECANE, SODIUM CITRATE,
VP/EICOSENE COPOLYMER, CAPRYLYL GLYCOL, PEG-8 LAURATE,
DISODIUM EDTA, XANTHAN GUM, POLYSORBATE 60, CITRIC ACID,
ISOCETETH-20, SORBITAN ISOSTEARATE, PARFUM/FRAGRANCE.

image of PDPimage of carton

ANEW SOLAR ADVANCE  SUNSCREEN BODY
homosalate, octisalate, oxybenzone, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0239
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE ) HOMOSALATE 80 mg  in 1 g
OCTISALATE (OCTISALATE ) OCTISALATE 7.125 mg  in 1 g
OXYBENZONE (OXYBENZONE ) OXYBENZONE 47.5 mg  in 1 g
AVOBENZONE (AVOBENZONE ) AVOBENZONE 28 mg  in 1 g
OCTOCRYLENE (OCTOCRYLENE ) OCTOCRYLENE 25 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:10096-0239-21 in 1 CARTON
1NDC:10096-0239-1150 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/20/201003/15/2013
Labeler - Avon Products, Inc. (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc.005149471manufacture(10096-0239)

Revised: 03/2013
Document Id: 17442b7f-788d-4e1b-a768-d43e8d5e00f3
Set id: fe03c021-09fc-42e1-96ed-c6c9c09bb4b6
Version: 4
Effective Time: 20130315
 
Avon Products, Inc.