Label: GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE- avobenzone, octinoxate lipstick

  • NDC Code(s): 82715-108-01
  • 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 22, 2022

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

View All Sections
  • Drug Facts

  • Active ingredient

    Avobenzone 2.7% w/v
    Octinoxate 6% 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

    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.

  • Drug FactsInactive ingredients

    Hydrogenated Polyisobutene, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraisostearate, Glyceryl Rosinate, Octyldodecanol, C30-50 Alcohols, Phenyl Trimethicone, Polyethylene, Titanium Dioxide, Shea (Butyrospermum parkii) Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Phenoxyethanol, Polybutene, Tocopheryl Acetate, Glyceryl Behenate, Sodium Hyaluronate, Octadecyl Di-T-Butyl -4-Hydroxyhydrocinnamate, Iron Oxides*, D&C Red 6*.
    * contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    SPF 15

    DELICATE
    CHOCOLATE AROMA
    VITAMIN E

    Manufactured By:
    ERKUL COSMETICS San. Tic. A.S.,
    Petrol Ofisi Cad. No:1 Avcılar, Istanbul, Turkey, 34310

    Phone: +90 212 456 53 00

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

    MADE IN TURKEY

    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

    choco cake-01

  • INGREDIENTS AND APPEARANCE
    GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE 
    avobenzone, octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-108
    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 POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    C30-50 ALCOHOLS (UNII: 4MCU204619)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: V88J661G2P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-108-013 g 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(82715-108)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!