Label: GR NUDE LOOK SPF 25- avobenzone, octinoxate cream

  • NDC Code(s): 82715-103-01, 82715-103-02, 82715-103-03
  • 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 23, 2022

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

  • Drug Facts

  • Active ingredients

    Avobenzone 0.25% w/v
    Octinoxate 2.5% 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), Diphenylsiloxy Phenyl Trimethicone, Caprylyl Methicone, Dimethicone, Butylene Glycol, Glycerin, Bellis Perennis (Daisy) Flower Extract, Peg-9 Polydimethylsiloxyethyl Dimethicone, Phenoxyethanol, Acrylates/Dimethicone Copolymer, Dimethicone/Peg-10/15 Crosspolymer, Magnesium Sulfate, Tocopheryl Acetate, Linoleic Acid, Titanium Dioxide, Peg-8, Sodium Chloride, Pentylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Aluminum Hydroxide, Tocopherol, Lactic acid, Fragrance, Serine, Sodium Lactate, Sorbitol, Urea, Ethylhexylglycerin, Disodium Edta, Sodium Hyaluronate, Alumina, Stearic Acid, Ascorbyl Palmitate, Dipropylene Glycol, Potassium Sorbate, Sodium Citrate, Ascorbic Acid, Citric Acid, Linolenic Acid, Allantoin, Disodium Phosphate. *Iron Oxides.
    *contains one or more of these ingredients.

  • SPL UNCLASSIFIED SECTION

    GOLDEN ROSE

    RADIANT TINTED MOISTURISER

    HYDRATING SKIN TINT

    Broad Spectrum SPF 25

    01 FAIR TINT

    02 MEDIUM TINT

    03 DEEP TINT

    • Radiant tinted moisturiser gives a healthy and fresh looking for the "no make-up look".
    • The advanced non oily formula infused with hydrating complex and vitamins.
    • SPF 25 sun protection shields your skin from the sun's harmful rays.

    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 167TH ST.
    MIAMI GARDENS,
    FL 33054 – USA

    info@celesty.com

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

  • Packaging

    ERKUL-103

  • INGREDIENTS AND APPEARANCE
    GR NUDE LOOK SPF 25 
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.25 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SERINE (UNII: 452VLY9402)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITOL (UNII: 506T60A25R)  
    UREA (UNII: 8W8T17847W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82715-103-011 in 1 CARTON07/22/2022
    132 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82715-103-021 in 1 CARTON07/22/2022
    232 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:82715-103-031 in 1 CARTON07/22/2022
    332 mL in 1 TUBE; Type 0: Not a Combination Product
    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(82715-103)