Label: PAPA RECIPE HONEY MOIST SUN ESSENCE- octinoxate, homosalate, octisalate, titanium dioxide 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 May 9, 2019

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  • ACTIVE INGREDIENT

    Active ingredients:

    Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Isononyl Isononanoate, Ethylhexyl Triazone, Glycerin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Sodium Hyaluronate, Biosaccharide Gum-4, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Allantoin, Sorbitan Isostearate, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Polysorbate 80,
    Sorbitan Oleate, Xanthan Gum, Sophora Japonica Fruit Extract, Propolis Extract, Pancratium Maritimum Extract, Fomes Officinalis (Mushroom) Extract, Royal Jelly Extract, Honey Extract

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep out of reach of children. Keep out of direct sunlight.

  • DESCRIPTION

    Uses
    ■ Helps prevent skin from excessive exposure to UV rays
    ■ Helps moisturize and refresh your skin that is easy to be dehydrated under the sun for long hours
    ■ Provides a gentle application without greasy or sticky feeling

    Directions
    ■ For face, apply a dime-sized amount liberally and gently over your entire skin before sun exposure after your ritual daily moisturization.
    ■ For body, apply liberally and uniformly to any exposed areas of your body before sun exposure or long-hour outdoor activities to ensure sun protection.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PAPA RECIPE HONEY MOIST SUN ESSENCE 
    octinoxate, homosalate, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73020-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.50 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.50 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.74 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73020-050-021 in 1 CARTON03/01/2019
    1NDC:73020-050-0150 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 finalpart35203/01/2019
    Labeler - Costory Co., Ltd (694893916)
    Registrant - Costory Co., Ltd (694893916)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(73020-050)