GR CC BROAD SPECTRUM SPF 30- octinoxate, oxybenzone cream

GR CC Broad Spectrum SPF 30 by

Drug Labeling and Warnings

GR CC Broad Spectrum SPF 30 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 6% w/v
Oxybenzone 2% 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), 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.

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

GR CC BROAD SPECTRUM SPF 30 
octinoxate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82715-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
PEG-40 STEARATE (UNII: ECU18C66Q7)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TALC (UNII: 7SEV7J4R1U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STRELITZIA NICOLAI WHOLE (UNII: YY9ZE10P9H)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
LUVISET 360 (UNII: 05BG6GY6YK)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FRUCTOSE (UNII: 6YSS42VSEV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
UREA (UNII: 8W8T17847W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TROMETHAMINE (UNII: 023C2WHX2V)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALLANTOIN (UNII: 344S277G0Z)
MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREHALOSE (UNII: B8WCK70T7I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
C11-15 PARETH-7 (UNII: 261HPE0IS3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CHROMIC OXIDE (UNII: X5Z09SU859)
ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82715-102-01	1 in 1 CARTON	07/22/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82715-102-02	1 in 1 CARTON	07/22/2022
2		30 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82715-102-03	1 in 1 CARTON	07/22/2022
3		30 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 82715-102-04	1 in 1 CARTON	07/22/2022
4		30 mL in 1 TUBE; 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(82715-102)