Label: EAUDELEMAN COSMETIC UV LIQUID- titanium dioxide lotion

  • 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 November 4, 2015

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  • ACTIVE INGREDIENT

    Titanium Dioxide  5.0%

  • PURPOSE

    Titanium Dioxide        Sunscreen 

  • Indications and Usage

    Helps prevent sunburn.

    Higher SPF gives more sunburn protection.

  • Directions

    Squeeze out a few drops of UV lotion the size of a pearl. Apply liberally before sun exposure to the entire face.

  • Warnings

    For external use only. Do not use on damaged or broken skin.

  • Keep Out of Reach of Children.

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

  • Avoid Contact With Eyes.

    If contact occurs, flush thoroughly with water.

  • STOP USE AND ASK A DOCTOR IF

    Rash, irritation and/or abnormal reaction develop and last.

  • Storage

    Store product at room temperature. Avoid exposure to excessive heat and direct sunlight. Use within 3-6 months if opened. Can be stored up to 2 years if unopened.

  • Questions or Comments?

    Manufactured by Eaudeleman Cosmetic

    Nishi Shinjuku 7-16-7, Shinjuku-ku, Tokyo 160-0023                       

    Made in Japan


    Distributed by JUC Group Inc.

    411 East Huntington Drive, Suite 205

    Arcadia, CA 91006

    (626)574-8588

    www.silkriller.com

  • INACTIVE INGREDIENTS

    WATER, SILK FIBROIN, SQUALANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILK, BASE HYDROLYZED (1000 MW), GLYCERIN, BUTYLENE GLYCOL, ALUMINUM OXIDE, STEARIC ACID, CHLORAMPHENICOL PALMITATE, SILICON DIOXIDE, SHEANUT OIL, TOCOPHEROL, DOCOSANOL, SIMMONDSIA CHINENSIS SEED, RICE BRAN OIL, COCOA BUTTER, CANDELILLA WAX, HYDROGENATED CASTOR OIL, COCONUT OIL, HONEY, RICINUS COMMUNIS SEED, OLIVE OIL, XANTHAN GUM, CARRAGEENAN, SUCROSE, JUGLANS REGIA SHELL, RIBOFLAVIN, D&C RED NO.7, METHYLPARABEN, PROPYLPARABEN

  • DRUG FACTS

    image description

  • INGREDIENTS AND APPEARANCE
    EAUDELEMAN COSMETIC UV LIQUID 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69893-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILK FIBROIN (UNII: M09888Y92S)  
    SQUALANE (UNII: GW89575KF9)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHLORAMPHENICOL PALMITATE (UNII: 43VU4207NW)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEANUT OIL (UNII: O88E196QRF)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HONEY (UNII: Y9H1V576FH)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SUCROSE (UNII: C151H8M554)  
    JUGLANS REGIA SHELL (UNII: PJ10MT7VKA)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69893-301-0130 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2014
    Labeler - Eaudeleman Cosmetic Co Ltd (711729371)
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