Label: RENEWING ANTIOXIDANT TREATMENT SPF 6 GNLD INTERNATIONAL- octyl methoxycinnamate, avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 16, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Octyl Methoxycinnamate 6.0 % Sunscreen

    Avobenzone 1.7 % Sunscreen

  • PURPOSE

    Uses

    helps prevent sunburn

    higher SPF gives more sunburn protection

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • WARNINGS

    Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This prduct has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For External use only

    Do not use on damaged or broken skin

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

  • DOSAGE & ADMINISTRATION

    Directions

    after moisturizing, apply evenly to entire face and neck

    apply liberally 15 minutes before sun exposure

    use a water resistant sunscreen if swimming or sweating

    reapply at least every 2 hours

    children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Water, PPG-2 Myristyl Ether Propionate, Butylene Glycol, Glyceryl Stearate, Tocopheryl Acetate, Decyl Oleate, Hydrogenated Coco-Glycerides, Isostearyl Isostearate, Cetearyl Alcohol, Dimethicone, Stearyl Alcohol, Shea Butter Extract, Olive Oil, Cyclomethicone, Hydrolysed Milk Protein, Niacinamide, Adenosine Triphosphate, Retinyl Palmitate, Peanut Oil, Lecithin, Ascorbyl Palmitate, Tocopherol, Green Tea Extract, Coneflower Extract, Xanthan Gum,Propylene Glycol, Disodium EDTA, Myristyl Alcohol, Myreth-4, Ceteareth-15, Ceteareth-20, Ceteareth-25, Cetyl Alcohol, PEG-30 Stearate, Fragrance, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben and Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    Renewing Antioxidant Treatment

    Antioxidant Cream with sunscreen SPF 6

    Net. Wt. 1.7 oz./ 50 g

    Back

    image of front label

    image of jar label

  • INGREDIENTS AND APPEARANCE
    RENEWING ANTIOXIDANT TREATMENT SPF 6  GNLD INTERNATIONAL
    octyl methoxycinnamate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76169-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SHEANUT OIL (UNII: O88E196QRF)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PEANUT OIL (UNII: 5TL50QU0W4)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CETEARETH-15 (UNII: 867H4YOZ8Z)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-30 STEARATE (UNII: 1U8KB35S20)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76169-101-021 in 1 BOX
    1NDC:76169-101-0150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/22/2011
    Labeler - GNLD International (948995019)
    Registrant - GNLD International (948995019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture(76169-101)
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