Label: GR BB SPF 25- octinoxate, oxybenzone, titanium dioxide cream

  • NDC Code(s): 82715-101-01, 82715-101-02, 82715-101-03, 82715-101-04, view more
    82715-101-05, 82715-101-06
  • 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 May 4, 2022

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

  • Drug Facts

  • Active ingredients

    Octinoxate 2.5% w/v
    Oxybenzone 0.25% w/v
    Titanium Dioxide 4.95% 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, Isododecane, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Phenyl Trimethicone, Talc, Acrylates/Dimethicone Copolymer, Silica Dimethyl Silylate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Tocopheryl Acetate, PEG/PPG-18 /18 Dimethicone, White Bird of Paradise (Strelitzia nicolai) Seed Aril Extract, Propylene Carbonate, Pentylene Glycol, Potassium Sorbate, Disodium EDTA, Sorbic Acid, Triethoxycaprylylsilane, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Magnesium Stearate, Fragrance, Silica, Isoceteth-10, Aluminum Hydroxide, Allantoin, Linalool, Mica*, Iron Oxides*, Bismuth Oxychloride*.
    * contains one or more of these ingredients

  • SPL UNCLASSIFIED SECTION

    BB CREAM

    BEAUTY BALM

    Broad Spectrum SPF 25

    All in One, Instantly Perfect Looking Skin!

    • Gives a smooth finish look with its light and easy to apply texture.
    • Provides hydration to the skin during the day.
    • SPF 25 (UVA/UVB) protects your skin against the harmful sunrays.

    DERMATOLOGICALLY TESTED

    Manufactured By:

    ERKUL COSMETICS
    San. Tic. A.Ş.
    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

    82715101-Label

  • INGREDIENTS AND APPEARANCE
    GR BB SPF 25 
    octinoxate, oxybenzone, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.25 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.95 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TALC (UNII: 7SEV7J4R1U)  
    2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    STRELITZIA NICOLAI WHOLE (UNII: YY9ZE10P9H)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SORBIC ACID (UNII: X045WJ989B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SERINE (UNII: 452VLY9402)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITOL (UNII: 506T60A25R)  
    UREA (UNII: 8W8T17847W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-101-011 in 1 CARTON06/06/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82715-101-021 in 1 CARTON06/06/2022
    230 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:82715-101-031 in 1 CARTON06/06/2022
    330 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:82715-101-041 in 1 CARTON06/06/2022
    430 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:82715-101-051 in 1 CARTON06/06/2022
    530 mL in 1 TUBE; Type 0: Not a Combination Product
    6NDC:82715-101-061 in 1 CARTON06/06/2022
    630 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/06/2022
    Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637)
    Establishment
    NameAddressID/FEIBusiness Operations
    ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI525225637manufacture(82715-101)