Label: TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM- ethylhexyl methoxycinnamate cream

  • Category: HUMAN OTC DRUG LABEL

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 February 4, 2016

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  • Active Ingredients

    Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

  • Purpose

    Sunscreen

  • Use

    This sun cream protects the skin effectively and continuously from strong ultraviolet sunlight. It has a highly-effective waterproof function so it cannot be easily washed off by water, sweat, or sebum, thereby maintaining its effect for many hours. It can be used on the face and body.

  • Caution

    For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Ethylhexyl Salicylate, PEG-10 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Aluminum Hydroxide, Stearic Acid, Methylparaben, Chlorphenesin, Fragrance(Parfum), Caffeine, Butylene Glycol, Propylparaben, Portulaca Oleracea Extract

  • Principal Display Panel

    sun cream

  • INGREDIENTS AND APPEARANCE
    TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM 
    other skin care preparations cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6295 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE27489 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTISALATE (UNII: 4X49Y0596W)  
    AMILOXATE (UNII: 376KTP06K8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-121-011 in 1 CARTON01/19/2016
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/14/2016
    Labeler - Tonymoly Co., Ltd. (688216798)
    Registrant - Tonymoly Co., Ltd. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(59078-121)
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