Label: ELASTOLOGY AGE BLOCKER- octinoxate, octisalate, titanium dioxide, and 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 September 1, 2011

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.0%sunscreen
    Octisalate 2.0%sunscreen
    Oxybenzone 3.0%sunscreen
    Titanium Dioxide 1.5%sunscreen
  • Uses

    • Helps prevent sun burn
    • Higher SPF gives more sun protection
  • Warnings

    For external use only.

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

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

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

  • Directions

    • Apply generously 30 minutes before sun exposure and as needed
    • Children under 6 months of age: ask a doctor
    • Reapply as needed or after towel drying, swimming or sweating
  • Other Information

    Sun Alert: Limited sun exposure, wearing protective clothing, and using a sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

  • Inactive Ingredients

    Aqua, Glycol Stearate SE, Propylene Glycol, Cetyl Alcohol, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Dicethyl Phosphate, Ceteth-10 Phosphate, DEA-Cetyl Phosphate, Acetyl Glucosamine, Saccharide Isomerate, Sodium Hyaluronate, Butylene Glycol, Centella Asiatica Extract, Echinacea Purpurea Extract, Squalane, Panthenol, Tocopheryl Acetate, Nelumbo Nucifera (Sacred Lotus) Seed Extract, Camellia Sinensis Extract, Pinus Strobus Bark Extract, Vitis Vinifera (Grape) Seed Extract, Glycerin, S-Adenosylmethionine, Pyridoxine HCl, Dimethyl Sulfone, Superoxide Dismutase, Cyclomethicone, Sodium Carboxymethyl Beta-Glucan, Magnesium Ascorbyl Phosphate, Ubiquinone, Retinyl Palmitate, Beta-Carotene, Xanthophyll, Lycopene, Methylparaben, Propylparaben, Hydroxyethylcellulose, Tetrasodium EDTA, Diazolidinyl Urea.

  • Questions or Comments?

    1-800-327-4660

    www.clientelebeauty.com

  • SPL UNCLASSIFIED SECTION

    Distributor:
    Clientele Inc., Sunrise, FL 33325 USA

  • PRINCIPAL DISPLAY PANEL - 34 g Jar Carton

    CLIENTELE®
    ELASTOLOGY®

    Sacred Lotus

    Age Blocker®
    SPF 25 Sunscreen

    34 g e 1.2 Oz

    PRINCIPAL DISPLAY PANEL - 34 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    ELASTOLOGY AGE BLOCKER 
    octinoxate, octisalate, titanium dioxide, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2 g  in 100 g
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX) 1 g  in 100 g
    Alpha-Tocopherol (UNII: H4N855PNZ1) 1 g  in 100 g
    Panthenol (UNII: WV9CM0O67Z) 1 g  in 100 g
    Water (UNII: 059QF0KO0R) 54.47 g  in 100 g
    Vitamin A (UNII: 81G40H8B0T) 120000 [iU]  in 100 g
    Cholecalciferol (UNII: 1C6V77QF41) 12000 [iU]  in 100 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64483-001-011 in 1 BOX
    134 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2000
    Labeler - Clientele, Inc. (085021806)