Label: SIORISYOU ARE MY SHINING SUNSCREEN- zinc oxide, 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 December 24, 2019

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  • ACTIVE INGREDIENT

    Active ingredients: ZINC OXIDE 16.15%, TITANIUM DIOXIDE 5.10%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Prunus Mume Fruit Water, Dicaprylyl Cabonate, Isoamyl Laurate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Ricinoleate, Bees- wax, Silica, Persea Gratissima (Avocado) Oil, Glycerin, Sorbitan Isostearate, Water, Sodium Chloride, Artemisia Montana Leaf Extract, Ginkgo Biloba Leaf Extract, Centella Asiatica Extract, Vaccinium Corymbosum (Blueberry) Fruit, Rosa Canina Fruit Oil, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium PCA, (-)-alpha-bisabolol, Tocopherol, Butylene Glycol, Stearic Acid, Aluminum Hydroxide, Citric Acid, Pelargonium Graveolens Flower Oil. Citrus Aurantium Dulcis (Orange) Peel Oil, Amyris Balsamifera Bark Oil, Helianthus Annuus (Sunflower) Seed Oil

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    (1) Immediately stop using in case of skin abnormalities after use.
    (2) Always recap after use.
    (3) Use as quickly as possible after opening.

  • DESCRIPTION

    Uses:
    ■ It can protect your skin from ultraviolet rays.

    Directions:
    ■ As the last step to your skincare regime, take an appropriate amount on the face and gently press the face with your palms for better absorption.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIORISYOU ARE MY SHINING SUNSCREEN 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73495-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.84 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.49 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PRUNUS MUME FRUIT OIL (UNII: I4HW888TQ6)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73495-020-021 in 1 CARTON12/20/2019
    1NDC:73495-020-0130 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 finalpart35212/20/2019
    Labeler - Zenkosmetikos Co., Ltd. (694793999)
    Registrant - Zenkosmetikos Co., Ltd. (694793999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elan Cosmetic Co.,ltd688204926manufacture(73495-020)
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