MedPath

GR SATIN SMOOTHING Fluid Foundation SPF 15

GOLDEN ROSE Fluid Foundation

Approved
Approval ID

1eba51f2-782e-480e-8555-f5ad8883fa0d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 6, 2025

Manufacturers
FDA

ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI

DUNS: 525225637

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Octinoxate, Oxybenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82715-104
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Oxybenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 6, 2025
FDA Product Classification

INGREDIENTS (33)

OCTINOXATEActive
Quantity: 1 g in 100 mL
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 0.1 g in 100 mL
Code: 95OOS7VE0Y
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYCLOMETHICONE 5Inactive
Code: 0THT5PCI0R
Classification: IACT
HYDROGENATED POLYDECENE (3100 CST)Inactive
Code: 4U179ML4TJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)Inactive
Code: 8INO2K35FA
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYGLYCERYL-3 DIISOSTEARATEInactive
Code: 46P231IQV8
Classification: IACT
DISTEARDIMONIUM HECTORITEInactive
Code: X687XDK09L
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
PROPYLENE CARBONATEInactive
Code: 8D08K3S51E
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
HYDROGEN DIMETHICONE (13 CST)Inactive
Code: 4QGR4P2YOI
Classification: IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)Inactive
Code: 5041RX63GN
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
LEVOMENOLInactive
Code: 24WE03BX2T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/25/2022

Packaging

ERKUL-104

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/25/2022

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/28/2022

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/25/2022

Active ingredients

Octinoxate 1% w/v
Oxybenzone 0.1% w/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/25/2022

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/26/2022

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/25/2022

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/25/2022

Other information

• protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/25/2022

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.

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GR SATIN SMOOTHING Fluid Foundation SPF 15 - FDA Drug Approval Details