Label: ANEW REJUVENATE DAY REVITALIZING- octinoxate, octisalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0305-1, 10096-0305-2, 10096-0305-3, 10096-0305-4, view more10096-0305-5, 10096-0305-6, 10096-0305-7 - Packager: Avon Products, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 30, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
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, SACCHAROMYCES LYSATE EXTRACT, KAEMPFERIA GALANGA ROOT EXTRACT, SACCHAROMYCES FERMENT FILTRATE, DIMETHICONE CROSSPOLYMER, 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW REJUVENATE DAY REVITALIZING
octinoxate, octisalate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 47.5 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0305-2 1 in 1 CARTON 1 NDC:10096-0305-1 50 g in 1 JAR 2 NDC:10096-0305-4 1 in 1 CARTON 2 NDC:10096-0305-3 15 g in 1 JAR 3 NDC:10096-0305-6 1 in 1 CARTON 3 NDC:10096-0305-5 7 g in 1 JAR 4 NDC:10096-0305-7 1.1 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/09/2013 Labeler - Avon Products, Inc (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0305)
