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

  • NDC Code(s): 82715-118-01
  • Packager: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 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, Astrocaryum Murumuru Seed Butter, Theobroma Grandiflorum Seed Butter, Caprylyl Glycol, Tocopheryl Acetate, Flavor, Octadecyl Di-T-Butyl-4-Hydroxyhydrocinnamate, Phenoxyethanol, *Titanium Dioxide, *Red 27, *Blue1 *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 Blueberry 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-BLUEBRY-1

  • INGREDIENTS AND APPEARANCE
    GR LIP BUTTER BLUEBERRY SPF 15 
    avobenzone, octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-118
    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)  
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBLUEBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-118-011 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(82715-118)