Label: GOLDEN ROSE CORRECT AND CONCEAL CONCEALER CREAM PALETTE- octinoxate powder

  • NDC Code(s): 82715-120-01, 82715-120-02
  • Packager: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Octinoxate 1.995% w/w

  • Purpose

    SunScreen

  • Uses

    • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

    Do not use • on damaged or broken skin

    When using this product • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if • rash occurs

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • 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 sun Broad Spectrum SPF value of 20 or higher and other 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

  • Other information

    • protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C-30°C.

  • Inactive ingredients

    Talc, Dimethicone, Silica, Polymethyl Methacrylate, Zinc Stearate, Diisostearyl Malate, Hexyl Laurate, Triethoxycaprylylsilane, Aluminum Hydroxide, Titanium Dioxide, Phenoxyethanol, Hydrogen Dimethicone, Allantoin, Dichlorobenzyl Alcohol, Magnesium Stearate, *Mica, *Iron Oxides
    *contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    Multi-use cream palette is ideal for correcting discolorations; concealing dark under-eye circles and spot imperfections or light shades for highlighting and dark shades for contouring your face features. Setting Powder with SPF 20 sets concealer and corrector for longwear make up.

    DERMATOLOGICALLY & OPHTHALMOLOGICALLY TESTED

    Setting Powder SPF 20
    IVORY Concealer
    NEUTRAL Concealer
    LIGHT BEIGE Corrector
    LIGHT BISQUE Corrector
    MEDIUM Corrector

    Manufactured By: 
    ERKUL COSMETICS San. Tic. A.S., 
    Petrol Ofisi Cad. No:1 Avcılar, ÍSTANBUL, TÜRKÍYE, 34310
    Phone: +90 212 456 53 00

    www.goldenrose.com.tr    info@goldenrose.com.tr

    MADE IN TÜRKÍYE

    Distributed By:
    CELESTY LLC
    3970 NW 167TH ST. MIAMI GARDENS, FL 33054-USA
    info@celesty.com

  • Packaging

    Concealer-120

  • INGREDIENTS AND APPEARANCE
    GOLDEN ROSE CORRECT AND CONCEAL CONCEALER CREAM PALETTE 
    octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.995 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-120-011 in 1 CARTON02/14/2024
    12 g in 1 CASE; Type 0: Not a Combination Product
    2NDC:82715-120-021 in 1 CARTON02/14/2024
    22 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/14/2024
    Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637)
    Establishment
    NameAddressID/FEIBusiness Operations
    ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI525225637manufacture(82715-120)