Label: ANEW ULTIMATE 7S DAY- homosalate, octinoxate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0266-1, 10096-0266-2, 10096-0266-3, 10096-0266-4, view more10096-0266-5 - Packager: Avon Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 20, 2011
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- 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, BUTYLENE GLYCOL, GLYCOLIC ACID, GLYCERIN, BEHENYL ALCOHOL, HYDROGENATED POLYISOBUTENE, TRISILOXANE, ETHYLHEXYL ISONONANOATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETEARYL ALCOHOL, ISOHEXADECANE, PHYTOL, THIODIPROPIONIC ACID, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ECLIPTA PROSTRATA EXTRACT, PALMITOYL LYSYL AMINOVALEROYL LYSINE, PALMITOYL TETRAPEPTIDE-10, PALMITOYL TETRAPEPTIDE-7, MELICOPE HAYESII LEAF EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, THIAZOLYLALANINE, MESYLOXYBENZYL ISOBUTYLBENZENESULFONAMIDE, PEG-100 STEARATE, CETEARYL GLUCOSIDE, DIMETHICONOL, POLYSORBATE 60, PEG-150 DISTEARATE, XANTHAN GUM, ISOMALT, LECITHIN, STEARETH-20, AMMONIUM HYDROXIDE, PHENOXYETHANOL, DISODIUM EDTA, PARFUM/FRAGRANCE, CARAMEL, RED 4/CI 14700.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW ULTIMATE 7S DAY
homosalate, octinoxate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0266 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4 g in 50 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 50 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.425 g in 50 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0266-2 1 in 1 CARTON 1 NDC:10096-0266-1 50 g in 1 JAR 2 NDC:10096-0266-4 1 in 1 CARTON 2 NDC:10096-0266-3 15 g in 1 JAR 3 NDC:10096-0266-5 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 12/20/2011 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 005149471 manufacture