Label: ANEW VITALE DAY- octinoxate, octisalate, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71110-0008-1 - 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 June 1, 2018
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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, dimethicone, glycerin, PEG-8, butyloctyl salicylate, cetearyl alcohol, trisiloxane, dilauryl thiodipropionate, phytol, behenyl alcohol,
thiodipropionic acid, panthenol, mesyloxybenzyl methoxyethyl chlorobenzamide, pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10, kaempferia galanga root extract, polysorbate 60, ceteareth-20, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dimethicone crosspolymer, isohexadecane, carbomer, sodium hydroxide, disodium EDTA, caprylyl glycol, 1,2-hexanediol, parfum/fragrance. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW VITALE DAY
octinoxate, octisalate, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71110-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 60 (UNII: CAL22UVI4M) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERIN (UNII: PDC6A3C0OX) THIODIPROPIONIC ACID (UNII: 3BBK323ED8) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PANTHENOL (UNII: WV9CM0O67Z) TRISILOXANE (UNII: 9G1ZW13R0G) DILAURYL THIODIPROPIONATE (UNII: V51YH1B080) PHYTOL (UNII: 5BC2RZ81NG) MESYLOXYBENZYL METHOXYETHYL CHLOROBENZAMIDE (UNII: 3HB4C300XB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71110-0008-1 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(71110-0008)
