Label: QUEENS ROSE PERFECTION COVER CUSHION PACT- titanium dioxide, octinoxate, zinc oxide, octisalate powder

  • 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 March 24, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 9.59%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, Zinc Oxide 4.90%, ETHYLHEXYL SALICYLATE 4.5%

  • INACTIVE INGREDIENT

    Inactive ingredients: Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Cetyl Ethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Water, Mica (CI 77019), Glycerin, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Silica, Phenoxyethanol, Iron Oxides (CI 77492), Magnesium Sulfate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Tocopherol, Copper Tripeptide-1, Acetyl Hexapeptide-8

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns.

    Keep out of reach of children

  • DESCRIPTION

    Indications & Usage: Apply a thin, even layer using puff.

    Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face..

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    QUEENS ROSE PERFECTION COVER CUSHION PACT 
    titanium dioxide, octinoxate, zinc oxide, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71252-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.15 g  in 12 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.84 g  in 12 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.58 g  in 12 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.54 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71252-120-022 in 1 CARTON03/02/2017
    1NDC:71252-120-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/02/2017
    Labeler - Cdpharmtec Co.,ltd (694209262)
    Registrant - Cdpharmtec Co.,ltd (694209262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cdpharmtec Co.,ltd694209262relabel(71252-120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71252-120)
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