Label: ANEW ULTIMATE DAY MULTI-PERFORMANCE- homosalate, octinoxate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71110-0013-1 - 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 June 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- children under 6 month of age:ask a doctor
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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, glycerin, dimethicone, butylene glycol, glycolic acid, behenyl alcohol, hydrogenated polyisobutene, trisiloxane, ethylhexyl isononanoate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetearyl alcohol, isohexadecane, phytol, thiodipropionic acid, PEG-100 stearate, ammonium hydroxide, parfum/fragrance, cetearyl glucoside, phenoxyethanol, dimethiconol, polysorbate 60, disodium EDTA, PEG-150 distearate, maltodextrin, tiliacora triandra leaf/vine extract, thiazolylalanine, saccharomyces ferment lysate filtrate, eclipta prostrata extract, saccharomyces/platinum ferment, isomalt, propylene glycol, SD alcohol 40-B, saccharomyces/copper ferment, saccharomyces/magnesium ferment, saccharomyces/malachite ferment, saccharomyces/tourmaline ferment, saccharomyces/zinc ferment, steareth-20, lecithin, vitis vinifera (grape) fruit cell extract, palmitoyl tetrapeptide-10, palmitoyl tetrapeptide-7, palmitoyl lysyl aminovaleroyl lysine, caramel, red 4/CI 14700. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW ULTIMATE DAY MULTI-PERFORMANCE
homosalate, octinoxate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71110-0013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29 mg in 1 g Inactive Ingredients Ingredient Name Strength STEARETH-20 (UNII: L0Q8IK9E08) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCOLIC ACID (UNII: 0WT12SX38S) POLYSORBATE 60 (UNII: CAL22UVI4M) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) MALTODEXTRIN (UNII: 7CVR7L4A2D) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CARAMEL (UNII: T9D99G2B1R) FD&C RED NO. 4 (UNII: X3W0AM1JLX) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRISILOXANE (UNII: 9G1ZW13R0G) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) THIODIPROPIONIC ACID (UNII: 3BBK323ED8) PHENOXYETHANOL (UNII: HIE492ZZ3T) ISOHEXADECANE (UNII: 918X1OUF1E) PHYTOL (UNII: 5BC2RZ81NG) PEG-100 STEARATE (UNII: YD01N1999R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) THIAZOLYLALANINE (UNII: VTL1Y3S44B) ISOMALT (UNII: S870P55O2W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71110-0013-1 1.1 g in 1 PACKET; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2016 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Manufacturing (Guangzhou) Ltd 544863277 manufacture(71110-0013)