Label: MALIN AND GOETZ SPF 15 FACE MOISTURIZER- octinoxate, octisalate, oxybenzone cream

  • 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 November 2, 2012

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  • ACTIVE INGREDIENT

    Active ingredients purpose

    Octinoxate 7.5% Sunscreen

    Octisalate 5% Sunscreen

    Oxybenzone 2% Sunscreen

    Uses

    For skin highly sensitive for sunburn

    helps prevent sunburn

    higher SPF gives more sunburn protection

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

    Stop use and ask a doctor if skin rash occurs

    Warnings

    For external use only

    UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothin and using a sunscreen

    Directions
    Apply liberally before sun exposure. Apply and reapply as directed to avoid lowering protection.
    Reapply at least every 2 hours. Children under 6 months: Ask a doctor

    Water (Aqua), Octyl Dodecyl Neopentanoate, Isocetyl stearate, glycerin, cetyl alcohol, glyceryl stearate, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (olive) Fruit oil, Butyrospermum Parkii (Shea butter), Ormenis Multicaulis, Tocopheryl Acetate, Butylene Glycol, Camellia Oleifera Leaf Extract, Magnesium Ascorbyl Phosphate, Cyano-cobalamin, Cholecalciferol, Retinyl Palmitate, C13-C16 Isoparaffin, C12-C14 Isoparaffin, C13-C15 Alkane, Titanium Dioxide, Polysorbate 80, Carbomer, Triethanolamine, phenoxyethanol, Sodium Dehydroacetate.

  • PRINCIPAL DISPLAY PANEL

    image of bottle

    (Malin + Goetz)

    spf 15 face moisturizer.

    UVA +UVB Broad Spectrum. All skin types. Fatty Acid Absorption technology-FM-110-04

    4 fl. oz. e 118ml.

  • INGREDIENTS AND APPEARANCE
    MALIN AND GOETZ  SPF 15 FACE MOISTURIZER
    octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53634-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CLADANTHUS MIXTUS FLOWER VOLATILE OIL (UNII: RAY2FRM711)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOMER 934 (UNII: Z135WT9208)  
    trolamine (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53634-152-01118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/02/2012
    Labeler - Malin & Goetz Inc (138615930)
    Registrant - Malin & Goetz Inc (138615930)
    Establishment
    NameAddressID/FEIBusiness Operations
    D'ARCY ACQUISITION, LLC101381952manufacture(53634-152)
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