GR SATIN SMOOTHING FLUID FOUNDATION SPF 15- octinoxate, oxybenzone liquid

GR SATIN SMOOTHING Fluid Foundation SPF 15 by

Drug Labeling and Warnings

GR SATIN SMOOTHING Fluid Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

GR SATIN SMOOTHING FLUID FOUNDATION SPF 15 
octinoxate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82715-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82715-104-01	1 in 1 CARTON	07/22/2022
1		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 82715-104-02	1 in 1 CARTON	07/22/2022
2		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 82715-104-03	1 in 1 CARTON	07/22/2022
3		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 82715-104-04	1 in 1 CARTON	07/22/2022
4		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 82715-104-05	1 in 1 CARTON	07/22/2022
5		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 82715-104-06	1 in 1 CARTON	07/22/2022
6		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 82715-104-07	1 in 1 CARTON	07/22/2022
7		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 82715-104-08	1 in 1 CARTON	07/22/2022
8		34 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 82715-104-09	1 in 1 CARTON	07/22/2022
9		34 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/22/2022

Labeler - ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (525225637)

Establishment
Name	Address	ID/FEI	Business Operations
ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI		525225637	manufacture(82715-104)