GR SATIN SMOOTHING FLUID FOUNDATION SPF 15- octinoxate, oxybenzone liquid 
ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

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.

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GR GOLDEN ROSE SATIN SMOOTHING Fluid Foundation

Drug Facts

Active ingredients

Octinoxate 1% w/v
Oxybenzone 0.1% 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, Hydrogenated Polydecene, Glycerin, Propylene Gylcol, Cetyl Peg/Ppg-10/1 Dimethicone, Talc, Polyglyceryl-3 Diisostearate, Disteardimonium Hectorite, Phenoxyethanol, Peg/Ppg-18/18 Dimethicone, Sodium Chloride, Dimethicone, Silica Dimethyl Silylate, Propylene Carbonate, Aluminum Hydroxide, Hydrogen Dimethicone, Trimethylsiloxysilicate, Allantoin, Sodium Benzoate, Xanthan gum, Titanium Dioxide, Tocopheryl Acetate, Fragrance, Disodium Edta, Bisabolol, Magnesium Stearate, Ethylhexylglycerin, Triethoxycaprylylsilane *Iron Oxides. *contains one or more of these ingredients.

GOLDEN ROSE

SPF 15

VITAMIN E

DERMATOLOGICALLY TESTED

Manufactured By:
ERKUL COSMETICS San. Tic. A.Ş.,
Petrol Ofisi Cad. 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 167TH ST.
MIAMI GARDENS,
FL 33054 – USA

info@celesty.com

EU R.P.: REACH Global Services SA, 
6 Rond point Schuman Brussels
1040 BELGIUM

NO:21

Packaging

ERKUL-104

GR SATIN SMOOTHING FLUID FOUNDATION SPF 15 
octinoxate, oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82715-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HYDROGENATED POLYDECENE (3100 CST) (UNII: 4U179ML4TJ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
TALC (UNII: 7SEV7J4R1U)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LEVOMENOL (UNII: 24WE03BX2T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82715-104-011 in 1 CARTON07/22/2022
134 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:82715-104-021 in 1 CARTON07/22/2022
234 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:82715-104-031 in 1 CARTON07/22/2022
334 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:82715-104-041 in 1 CARTON07/22/2022
434 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:82715-104-051 in 1 CARTON07/22/2022
534 mL in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:82715-104-061 in 1 CARTON07/22/2022
634 mL in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:82715-104-071 in 1 CARTON07/22/2022
734 mL in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:82715-104-081 in 1 CARTON07/22/2022
834 mL in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:82715-104-091 in 1 CARTON07/22/2022
934 mL in 1 BOTTLE; 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(82715-104)

Revised: 7/2022
Document Id: ea2163ef-e487-4aa3-81be-58df90466f17
Set id: 1eba51f2-782e-480e-8555-f5ad8883fa0d
Version: 1
Effective Time: 20220725
 
ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI