Label: FACE MOISTURISER- avobenzone and octinoxate lotion

  • 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 8, 2014

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  • ACTIVE INGREDIENT

    Avobenzone and Octinoxate

  • PURPOSE

    Face Moisturiser + Sunscreen SPF 15

    Atlantic Ocean Brown Algae

    (Homeo-Sheild®) Green Algae Extract (Homeoxy®)

    Vitamin A, B & E Rosemary Mint

    Milk & co

    150 ML (5 FL OZ)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Milk Face Moisturiser + Sunscreen is a non greasy daily moisturiser that will help nourish, replenish and protect the skin against UV damage and free radicals. The combination of marine extracts with vitamins A, B and E will aid in leaving the skin hydrated and protected. The rosemary mint aroma awakens the senses.

  • WARNINGS

    Caution: for external use. If irritation or rash develops discontinue use.

  • DOSAGE & ADMINISTRATION

    To use: apply daily to face and neck.

  • INACTIVE INGREDIENT

    Ingredients: aqua, octyl methoxycinnamate, cyclomethicone, glycerin, dimethicone, dimethicone crosspolymer, c12-15 alkyl benzoate, styrene/acrylates copolymer, butyl methoxydibenzoylmethane, cetyl olivate, sorbitan olivate, sodium acrylate/acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, fucus serratus extract, enteromorpha campressa extract, palmaria palamata extract, xanthan gum, acrylate copolymer, disodium EDTA, pentylene glycol, sodium lactate, lactate acid, serine, urea, sorbitol, sodium chloride, panthenol, diazolidinylurea, methylparaben, propylparaben, parfum.

  • OTHER SAFETY INFORMATION

    Manufactured for: 

    Milk & Co Pty Ltd

    Lower Level, Rear 568

    Chapel Street, South Yarra

    Victoria Australia 3141

    www.milkandco.com.au

    Nutra Management LLC

    626C Admiral Dr.

    Unite 314 Annapolis,

    Maryland 21401 USA

    Made in Australia

    Store below 30oC / 86oF

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    FACE MOISTURISER 
    avobenzone and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61671-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 150 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    FUCUS SERRATUS (UNII: V8K40WNW5B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DULSE (UNII: 7832HOY4ZQ)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SERINE (UNII: 452VLY9402)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SORBITOL (UNII: 506T60A25R)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    UREA (UNII: 8W8T17847W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61671-004-01150 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/08/2014
    Labeler - Milk & Co Pty Ltd (754955045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Milk & Co Pty Ltd754955045manufacture(61671-004)