AVON NUTRA EFFECTS BALANCE DAY CREAM (OCTINOXATE, HOMOSALATE, AVONBENZONE, OXYBENZONE) CREAM [AVON PRODUCTS, INC.]

AVON NUTRA EFFECTS BALANCE DAY CREAM (OCTINOXATE, HOMOSALATE, AVONBENZONE, OXYBENZONE) CREAM [AVON PRODUCTS, INC.]
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NDC 71110-0015-1
Set ID 6d9a1754-8d48-054f-e053-2991aa0a4653
Category HUMAN OTC DRUG LABEL
Packager Avon Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinoxate 5.5%......

    Homosalate 5.0%....

    Avonbenzone 2.9%.....

    Oxybenzone 1.0%......

  • PURPOSE

    Purpose

    ............Sunscreen

    ............Sunscreen

    ............Sunscreen

    ............Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburn.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product, keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    For suncreen use:

    Apply liberally and evenly 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-procteion measures, including:
    Limite time in the sun, expecially from 10 a.m.-2 p.m.
    Wear long-sleeved shirts, pants, hats and sunglasses.

  • STORAGE AND HANDLING

    Other Information

    • Protect the product in this container from excessive heat and direct sun,
    • Product may stain fabrics.
  • INACTIVE INGREDIENT

    Inactive ingredients

    WATER/EAU, BUTYLENE GLYCOL, DIMETHICONE, ETHYLHEXYL ISONONANOATE, PEG-8, SILICA, GLYCERIN, POLYSILICONE-11, CAPRYLYL GLYCOL, PARFUM/FRAGRANCE, GLYCERYL STEARATE, HYDROGENATED LECITHIN, PHENOXYETHANOL, BEHENYL ALCOHOL, CETYL ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, DISODIUM EDTA, PANTHENOL, TALC, CHOLETH-24, ISOHEXADECANE, SODIUM HYDROXIDE, HEXYLENE GLYCOL, CETETH-24, POLYGLYCERYL-3 DIISOSTEARATE, PYRIDOXINE HCL, POLYSORBATE 60, LAURETH-12, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PHYTOL, ISOMALT, MALTODEXTRIN, POUZOLZIA PENTANDRA EXTRACT, SALVIA HISPANICA SEED EXTRACT, LECITHIN, VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFB

  • INGREDIENTS AND APPEARANCE
    AVON NUTRA EFFECTS  BALANCE DAY CREAM
    octinoxate, homosalate, avonbenzone, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    TALC (UNII: 7SEV7J4R1U)  
    CHOLETH-24 (UNII: 5UE7I54O43)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CETETH-24 (UNII: 0EV3Z43Y2I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHYTOL (UNII: 5BC2RZ81NG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ISOMALT (UNII: S870P55O2W)  
    LAURETH-12 (UNII: OAH19558U1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71110-0015-11.1 g in 1 PACKET; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2016
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Manufacturing (Guangzhou) Ltd544863277manufacture(71110-0015)

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