Label: GR TOTAL COVER 2 IN 1 FOUNDATION AND CONCEALER SPF 15- octinoxate lotion

  • NDC Code(s): 82715-106-01, 82715-106-02, 82715-106-03, 82715-106-04, view more
    82715-106-05, 82715-106-06, 82715-106-07, 82715-106-08, 82715-106-09, 82715-106-10, 82715-106-11, 82715-106-12, 82715-106-13, 82715-106-14, 82715-106-15, 82715-106-16, 82715-106-17, 82715-106-18, 82715-106-19, 82715-106-20, 82715-106-21, 82715-106-22, 82715-106-23, 82715-106-24, 82715-106-25
  • 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 26, 2022

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  • Drug Facts

  • Active ingredients

    Octinoxate 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 skinWhen 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, Dimethicone, Peg-10 Dimethicone, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Caprylyl Methicone, Trımethylsiloxysilicate, Propylene Glycol, Silica Dimethyl Silylate, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Polypropylsılsesquioxane, Sodıum Chloride, Zinc Pca, Phenoxyethanol, Silica, Dimethicone Crosspolymer, Peg-12 Dimethicone/Ppg-20 Crosspolymer, Tocopheryl Acetate, Peg/Ppg-18/18 Dimethicone, Talc, Isododecane, Xanthan Gum, Triethoxycaprylylsilane, Titanium Dioxide, Ethylhexylglycerın, Disodium Edta, Isoceteth-10, Fragrance, Magnesium Stearate, Aluminum Hydroxide, Linalool. * Iron Oxides. *contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    SPF 15

    Vitamin E

    01 PORCELAIN

    •Full Coverage & Longwear
    •Semi-Matte & Smooth Finish
    •Lightweight/Non-Oily Formula

    DERMATOLOGICALLY TESTED

    ERKUL KOZMETIK San. Tic. A.Ş.,
    P.Ofisi Cd. No:1 Avcılar, IST./TURKEY

    MADE IN TURKEY

    EU R.P: Platin Beauty Consulting UG
    (haftungsbeschränkt)
    Bardowicker Str. 6,
    21335 Lüneburg/GERMANY

  • Packaging

    ERKUL-106

  • INGREDIENTS AND APPEARANCE
    GR TOTAL COVER 2 IN 1 FOUNDATION AND CONCEALER SPF 15 
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    TALC (UNII: 7SEV7J4R1U)  
    ISODODECANE (UNII: A8289P68Y2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-106-0130 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    2NDC:82715-106-0230 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    3NDC:82715-106-0330 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    4NDC:82715-106-0430 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    5NDC:82715-106-0530 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    6NDC:82715-106-0630 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    7NDC:82715-106-0730 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    8NDC:82715-106-0830 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    9NDC:82715-106-0930 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    10NDC:82715-106-1030 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    11NDC:82715-106-1130 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    12NDC:82715-106-1230 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    13NDC:82715-106-1330 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    14NDC:82715-106-1430 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    15NDC:82715-106-1530 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    16NDC:82715-106-1630 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    17NDC:82715-106-1730 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    18NDC:82715-106-1830 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    19NDC:82715-106-1930 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    20NDC:82715-106-2030 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    21NDC:82715-106-2130 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    22NDC:82715-106-2230 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    23NDC:82715-106-2330 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    24NDC:82715-106-2430 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    25NDC:82715-106-2530 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2022
    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(82715-106)
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