MedPath

GR CC Broad Spectrum SPF 30

GOLDEN ROSE

Approved
Approval ID

751d5194-f5ea-401b-9439-7770510a588c

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 Code82715-102
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 (54)

OCTINOXATEActive
Quantity: 6 g in 100 mL
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 2 g in 100 mL
Code: 95OOS7VE0Y
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)Inactive
Code: 59Z907ZB69
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
PEG-40 MONOSTEARATEInactive
Code: ECU18C66Q7
Classification: IACT
DOCOSANOLInactive
Code: 9G1OE216XY
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PHENYL TRIMETHICONEInactive
Code: DR0K5NOJ4R
Classification: IACT
POLYGLYCERYL-10 PENTASTEARATEInactive
Code: PMX5872701
Classification: IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)Inactive
Code: 86FQE96TZ4
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEAROYL LACTYLATEInactive
Code: IN99IT31LN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
STRELITZIA NICOLAI WHOLEInactive
Code: YY9ZE10P9H
Classification: IACT
SODIUM DEHYDROACETATEInactive
Code: 8W46YN971G
Classification: IACT
LUVISET 360Inactive
Code: 05BG6GY6YK
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
ISOPROPYL TITANIUM TRIISOSTEARATEInactive
Code: 949E3KBJ1I
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITAN ISOSTEARATEInactive
Code: 01S2G2C1E4
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
MALTOSE, UNSPECIFIED FORMInactive
Code: XJ6S9RV06F
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
SODIUM PYRROLIDONE CARBOXYLATEInactive
Code: 469OTG57A2
Classification: IACT
TREHALOSEInactive
Code: B8WCK70T7I
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
SODIUM LAURETH-12 SULFATEInactive
Code: 8M492LDU23
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
C11-15 PARETH-7Inactive
Code: 261HPE0IS3
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CHROMIC OXIDEInactive
Code: X5Z09SU859
Classification: IACT
ULTRAMARINE BLUEInactive
Code: I39WR998BI
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/23/2022

Packaging

ERKUL-102ERKUL-102

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/22/2022

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: 7/29/2022

GOLDEN ROSE

COLOR CORRECTING PRIMER

Correct • Brighten • Protect

Green correcting shade neutralises redness tone for a flawless make-up.
Orange correcting shade neutralises the look of dark circles & brown spots on medium to deep skin tones for a flawless make-up.
Violet correcting shade neutralises dull yellow undertones on light to medium skin tones for a flawless make-up.
Yellow correcting shade neutralises purple/blue tones corrects mild redness tone for a flawless make-up.

• Smooths, evens and brightens skin tone, hide dullness and dark spots.
• Contains skin friendly pure moisturiser complex.
• With SPF 30 to protect your skin against the harmful sunrays. Apply to cleaned skin. Can be used alone or under foundation.

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/22/2022

Active ingredients

Octinoxate 6% w/v
Oxybenzone 2% w/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/22/2022

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/22/2022

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: 7/22/2022

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: 7/22/2022

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: 7/23/2022

Inactive ingredients

Water(Aqua), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine.
*contains one or more of these ingredients.

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