Label: ANEW ULTIMATE DAY MULTI-PERFORMANCE- homosalate, octinoxate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0323-1, 10096-0323-2, 10096-0323-3, 10096-0323-4, view more10096-0323-5 - Packager: New Avon LLC
- 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 January 1, 2019
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. - QUESTIONS
- 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:10096-0323 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 WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0323-2 1 in 1 CARTON 12/19/2014 1 NDC:10096-0323-1 50 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:10096-0323-4 1 in 1 CARTON 12/19/2014 2 NDC:10096-0323-3 15 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:10096-0323-5 1.1 g in 1 PACKET; Type 0: Not a Combination Product 12/19/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/19/2014 Labeler - New Avon LLC (080143520)