Label: GR LIP BUTTER RASPBERRY SPF 15- avobenzone, octinoxate lipstick

  • NDC Code(s): 82715-114-01
  • Packager: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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

  • Drug Facts

  • Active ingredient

    Avobenzone 2.7% w/w
    Octinoxate 6% 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

    Do not use • on damaged or broken skin

    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 to cleansed lips • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m.-2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Other information

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

  • Inactive Ingredients

    Ppg-3 Hydrogenated Castor Oil, Neopentyl Glycol Diheptanoate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Synthetic Wax, Flavor, Titanium Dioxide, Astrocaryum Murumuru Seed Butter, Theobroma Grandiflorum Seed Butter, Caprylyl Glycol, Tocopheryl Acetate, Octadecyl Di-T-Butyl-4-Hydroxyhydrocinnamate, Phenoxyethanol, Alpha-Isomethyl Ionone, Eugenol, *Red 27, *Yellow 5 *contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    • Vitamin E

    • Keeps lips soft and smooth.

    • Cute shape

    • Easy to use.

    Lip Butter with Raspberry Flavour contains Cupuacu, Murumuru and Shea Butter to feel lips softened and hydrated.

    DERMATOLOGICALLY TESTED

    Manufactured By:
    ERKUL COSMETICS San. Tic. A.S.,
    P.Ofisi Cd. 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 167 TH
    ST.MIAMI GARDENS,
    FL 33054 - USA
    info@celesty.com

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

  • Packaging

    GRLIP-RASP1

  • INGREDIENTS AND APPEARANCE
    GR LIP BUTTER RASPBERRY SPF 15 
    avobenzone, octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: V88J661G2P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    EUGENOL (UNII: 3T8H1794QW)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-114-011 in 1 BOX10/25/2023
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/25/2023
    Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637)
    Establishment
    NameAddressID/FEIBusiness Operations
    ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI525225637manufacture(82715-114)