Label: TONYMOLY MAGIC FOOD MANGO MILD SUN BLOCK- octinoxate, octisalate, avobenzone, ensulizole, homosalate 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 January 20, 2016

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 6.9%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.5%, Phenylbenzimidazole Sulfonic Acid 3.5%, Homosalate 3.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Butylene Glycol, Alcohol Denat., Octocrylene, Phenethyl Benzoate, Aminomethyl Propanol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Triceteareth-4 Phosphate, Glycol Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, PEG-2 Stearate, Fragrance(Parfum), Phenoxyethanol, Glyceryl Caprylate, Caprylyl Glycol, Mangifera Indica (Mango) Seed Butter, Disodium EDTA, Citrus Limon (Lemon) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Propylene Glycol, 1,2-Hexanediol, Citrus Aurantium Dulcis (Orange) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Psidium Guajava Fruit Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ethylhexylglycerin

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only

    Do not use on damaged or broken skin

    Stop use and ask a doctor if irritation occurs

    Keep out of reach of children

  • DESCRIPTION

    Uses: - helps prevent sunburn - If used as directed with other sun protection measures

    Directions: decreases the risk of skin cancer and early skin aging caused by the sun

    Directions:

    For sunscreen use: - apply liberally 15 minutes before sun exposure - use a water resistant sunscreen if swimming or sweating - reapply at least every 2 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 value 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-sleeved shirts, pants, hats, and sunglasses - children under 6 months: Ask a doctor

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TONYMOLY MAGIC FOOD MANGO MILD SUN BLOCK 
    octinoxate, octisalate, avobenzone, ensulizole, homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.10 g  in 45 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.02 g  in 45 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.57 g  in 45 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.57 g  in 45 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.35 g  in 45 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-210-0145 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2015
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-210)