ANEW REVERSALIST DAY RENEWAL- octinoxate, octisalate, oxybenzone, avobenzone 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 7.11%, OCTISALATE 4.75%,
OXYBENZONE 4.00%, AVOBENZONE 2.85%.............................................................

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

• 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, DIMETHICONE, GLYCERIN, BUTYLENE GLYCOL,
ISODECYL ISONONANOATE, TROMETHAMINE, DILAURYL THIODIPROPIONATE, PHYTOL,
THIODIPROPIONIC ACID, THIAZOLYLALANINE, SESBANIA GRANDIFLORA FLOWER EXTRACT,
AMORPHOPHALLUS CAMPANULATUS RHIZOME/ROOT EXTRACT, PUNICA GRANATUM FRUIT
JUICE, PALMITOYL LYSYL AMINOVALEROYL LYSINE, TOCOPHEROL, POLYSORBATE 20,
CETEARYL ALCOHOL, KAEMPFERIA GALANGA ROOT EXTRACT, ISOHEXADECANE,
CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, NYLON-12,
POLYMETHYLSILSESQUIOXANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL
TAURATE COPOLYMER, XANTHAN GUM, CETEARETH-20, HYDROGENATED LECITHIN, SILICA,
POLYSORBATE 60, TRIMETHYLSILOXYSILICATE, SORBITAN ISOSTEARATE, DIMETHICONE
CROSSPOLYMER, POLYMETHYL METHACRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA,
PHENOXYETHANOL, PARFUM/FRAGRANCE.

Questions? Call 1-800-FOR-AVON

image of labelimage of DFB

ANEW REVERSALIST  DAY RENEWAL
octinoxate, octisalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0181
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE71.1 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.5 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40.0 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10096-0181-21 in 1 CARTON
1NDC:10096-0181-150 g in 1 JAR
2NDC:10096-0181-41 in 1 CARTON
2NDC:10096-0181-315 g in 1 JAR
3NDC:10096-0181-61 in 1 CARTON
3NDC:10096-0181-57 g in 1 JAR
4NDC:10096-0181-71.1 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/15/2009
Labeler - Avon Products, Inc (001468693)
Establishment
NameAddressID/FEIBusiness Operations
Avon Products, Inc005149471manufacture(10096-0181)

Revised: 2/2013
Document Id: efa124d3-d775-4ddf-b7ff-1be2581d72c0
Set id: e5cf56cb-f878-4b8a-aafd-4476a19fad14
Version: 2
Effective Time: 20130204
 
Avon Products, Inc