ANEW REJUVENATE DAY REVITALIZING- octinoxate, octisalate, avobenzone and oxybenzone cream 
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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Active ingredients
OCTINOXATE 7.5%, OCTISALATE 5.0%,
AVOBENZONE 3.0%, OXYBENZONE 3.0%.......................................

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

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

  • 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, DIMETHICONE, ISODECYL ISONONANOATE, GLYCERIN, BUTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, DILAURYL THIODIPROPIONATE, POLYMETHYL METHACRYLATE, THIODIPROPIONIC ACID, SALICYLIC ACID, ECLIPTA PROSTRATA EXTRACT, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, PALMITOYL TETRAPEPTIDE-7, SODIUM HYALURONATE, PHYLLANTHUS EMBLICA FRUIT EXTRACT, FOENICULUM VULGARE (FENNEL) SEED EXTRACT, YEAST EXTRACT/EXTRAIT DE LEVURE, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, SORBITAN ISOSTEARATE, SILICA, STEARETH-20, LACTOFERRIN, PHOSPHOLIPIDS, ISOHEXADECANE, HYDROGENATED LECITHIN, PHENOXYETHANOL, ACRYLATES/C10-30 ALKYL ACRYLATE
CROSSPOLYMER, CARBOMER, TROMETHAMINE, POLYSORBATE 60, METHYLPARABEN, DISODIUM EDTA, PROPYLPARABEN, PARFUM/FRAGRANCE, MICA/CI 77019, TITANIUM DIOXIDE/CI 77891.

Questions? 1-800-FOR-AVON

image of PDPimage of carton

ANEW REJUVENATE  DAY REVITALIZING
octinoxate, octisalate, avobenzone, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0167
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE30 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:10096-0167-21 in 1 CARTON
1NDC:10096-0167-150 g in 1 JAR
2NDC:10096-0167-41 in 1 CARTON
2NDC:10096-0167-315 g in 1 JAR
3NDC:10096-0167-61 in 1 CARTON
3NDC:10096-0167-57 g in 1 JAR
4NDC:10096-0167-71.1 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/09/201305/30/2013
Labeler - Avon Products, Inc (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc005149471manufacture(10096-0167)

Revised: 05/2013
 
Avon Products, Inc