DAILY CARE SUN (OCTINOXATE, TITANIUM DIOXIDE) CREAM [MIGUHARA]

DAILY CARE SUN (OCTINOXATE, TITANIUM DIOXIDE) CREAM [MIGUHARA]
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NDC 70380-160-01
Set ID 49f63197-b99e-4203-b7dd-8cb6360591a2
Category HUMAN OTC DRUG LABEL
Packager MIGUHARA
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 1.12%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cetearyl Alcohol, Isododecane, Butylene Glycol, Benzophenone-4, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Propylene Glycol, Cyclopentasiloxane, Helianthus Annuus (sunflower) Seed Oil, Triethanolamine, Acrylates Copolymer, Nylon-12, Microcrystalline Wax, BeesWax, Cyclomethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetearyl Glucoside, Stearic Acid, Palmitic Acid, Dimethicone, Butyrospermum Parkii (Shea) Butter, Sodium Polyacrylate, Tocopheryl Acetate, PEG/PPG-19/19 Dimethicone, Hexyl Laurate, Dimethicone Copolyol, Fragrance, Methyl Paraben, Carbomer, Ethylhexyl Stearate, Alumina, PropylParaben, Sodium Laureth Sulfate, Disodium EDTA, Trideceth-6, Bifida Ferment Lysate, Glycerin, Portulaca Oleracea Extract, Tocopherol, Hydrolyzed Collagen

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4) Its SPF and Ultraviolet rays were measured according to functional cosmetic regulation.

  • Usage

    Usage: Take an appropriate amount and gently apply it on the face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DAILY CARE SUN 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.50 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.56 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-160-0150 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIGUHARA689204213manufacture(70380-160)

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