UGLY DUCK MIRACLE MULTI SHIELD SUN GEL (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE,) GEL [EREPH CO., LTD]

UGLY DUCK MIRACLE MULTI SHIELD SUN GEL (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE,) GEL [EREPH CO., LTD]
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NDC 71624-100-01, 71624-100-02
Set ID fd26f2dd-26d6-42d5-80df-b4ef42c64925
Category HUMAN OTC DRUG LABEL
Packager EREPH CO., LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Ethylhexyl Methoxycinnamate (Octinoxate) (7%)

    Ethylhexyl Salicylate (Octisalate)(3%)

    Titanium Dioxide (1.494%)

  • Purpose

    Sunscreen

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Warnings

    For external use only
    Do not use when skin is red, inflamed, irritated, or painful
    When using this product
    - do not apply on other parts of the body
    - do not use on damaged or broken skin
    - avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    - do not apply directly to wound or open cut
    Stop use and ask a doctor if
    - Rash or irritation on skin develops and lasts

  • Uses

    Helps prevent sunburn

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • 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 of age: ask a doctor

  • Inactive Ingredients

    Water, Homosalate, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Sorbitan Isostearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT, Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Oleifera Seed Oil, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract,

  • Ugly Duck Miracle Multi Shield Sun Gel

    sun gel

  • INGREDIENTS AND APPEARANCE
    UGLY DUCK MIRACLE MULTI SHIELD SUN GEL 
    octinoxate, octisalate, titanium dioxide, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71624-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.2 g  in 60 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.8 g  in 60 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.8964 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Homosalate (UNII: V06SV4M95S)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Ethylhexyl Triazone (UNII: XQN8R9SAK4)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    Allantoin (UNII: 344S277G0Z)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TRIS-BHT MESITYLENE (UNII: 51DM34B894)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    Blackberry (UNII: 8A6OMU3I8L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71624-100-021 in 1 PACKAGE07/26/2017
    1NDC:71624-100-0160 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/26/2017
    Labeler - EREPH CO., LTD (690038933)
    Registrant - EREPH CO., LTD (690038933)
    Establishment
    NameAddressID/FEIBusiness Operations
    EREPH CO., LTD690038933relabel(71624-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd. 557795360manufacture(71624-100)

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