Label: GR SATIN SMOOTHING FLUID FOUNDATION SPF 15- octinoxate, oxybenzone liquid

  • NDC Code(s): 82715-104-01, 82715-104-02, 82715-104-03, 82715-104-04, view more
    82715-104-05, 82715-104-06, 82715-104-07, 82715-104-08, 82715-104-09
  • Packager: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 25, 2022

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  • Drug Facts

  • Active ingredients

    Octinoxate 1% w/v
    Oxybenzone 0.1% w/v

  • 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 15 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

    Water(Aqua), Cyclopentasiloxane, Hydrogenated Polydecene, Glycerin, Propylene Gylcol, Cetyl Peg/Ppg-10/1 Dimethicone, Talc, Polyglyceryl-3 Diisostearate, Disteardimonium Hectorite, Phenoxyethanol, Peg/Ppg-18/18 Dimethicone, Sodium Chloride, Dimethicone, Silica Dimethyl Silylate, Propylene Carbonate, Aluminum Hydroxide, Hydrogen Dimethicone, Trimethylsiloxysilicate, Allantoin, Sodium Benzoate, Xanthan gum, Titanium Dioxide, Tocopheryl Acetate, Fragrance, Disodium Edta, Bisabolol, Magnesium Stearate, Ethylhexylglycerin, Triethoxycaprylylsilane *Iron Oxides. *contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    GOLDEN ROSE

    SPF 15

    VITAMIN E

    DERMATOLOGICALLY TESTED

    Manufactured By:
    ERKUL COSMETICS San. Tic. A.Ş.,
    Petrol Ofisi Cad. No:1
    Avcılar, ISTANBUL, TURKIYE,
    34310

    Phone: +90 212 456 53 00

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

    MADE IN TURKIYE

    Distributed By:
    CELESTY LLC
    3970 NW 167TH ST.
    MIAMI GARDENS,
    FL 33054 – USA

    info@celesty.com

    EU R.P.: REACH Global Services SA, 
    6 Rond point Schuman Brussels
    1040 BELGIUM

    NO:21

  • Packaging

    ERKUL-104

  • INGREDIENTS AND APPEARANCE
    GR SATIN SMOOTHING FLUID FOUNDATION SPF 15 
    octinoxate, oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HYDROGENATED POLYDECENE (3100 CST) (UNII: 4U179ML4TJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-104-011 in 1 CARTON07/22/2022
    134 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:82715-104-021 in 1 CARTON07/22/2022
    234 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:82715-104-031 in 1 CARTON07/22/2022
    334 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:82715-104-041 in 1 CARTON07/22/2022
    434 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:82715-104-051 in 1 CARTON07/22/2022
    534 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:82715-104-061 in 1 CARTON07/22/2022
    634 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:82715-104-071 in 1 CARTON07/22/2022
    734 mL in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:82715-104-081 in 1 CARTON07/22/2022
    834 mL in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:82715-104-091 in 1 CARTON07/22/2022
    934 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/22/2022
    Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637)
    Establishment
    NameAddressID/FEIBusiness Operations
    ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI525225637manufacture(82715-104)
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