Label: ADVANCED ANTI AGING UNSCENTED WITH SUNSCREEN SPF 20- avobenzone, octinoxate, octisalate cream

  • NDC Code(s): 70879-824-02
  • Packager: Geneva Naturals USA, LLC
  • 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 May 3, 2017

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Avobenzone 3%
    Octinoxate 5%
    Octisalate 3%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

    Do not use on

    damaged or broken skin

    When using this product keep 

    out of eyes. Rinse with warm water to remove

    Stop use and ask a doctor 

    if rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:
    • apply to face and neck in the morning
    or 15 minutes before sun exposure
    • reapply at least every two hours
    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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor

  • Inactive Ingredients

    Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Algae Extract, C12-15 Alkyl Benzoate, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetearyl Gluucoside, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Ethylhexylglycerin, Fucus Algae Extract, C12-15 Alkyl Benzoate, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetearyl Alcohol, Cetearyl Gluucoside, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Ethylhexylglycerin, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Hyaluronic Acid, Hydrolyzed Collagen, Isopropyl Myristate, Isostearyl Palmitate, Leontopodium Alpinum (Edelweiss) Stem Cell Extract, Mangifera Indica (Mango) Seed Butter, Moringa Oleifera (Moringa) Oil, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Parfum (Fragrance), Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinol (Vitamin A), Saccharide Isomerate, Sodium Hydroxide, Sodium Pca, Tetrahexyldecyl Ascorbate (Vitamin C), Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin E)

  • Questions

    Call toll free 1-800-330-2321

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED ANTI AGING UNSCENTED WITH SUNSCREEN SPF 20 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70879-824
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    RETINOL (UNII: G2SH0XKK91)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70879-824-021 in 1 BOX05/03/2017
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/03/2017
    Labeler - Geneva Naturals USA, LLC (080280377)