GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE- avobenzone, octinoxate lipstick

GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE by

Drug Labeling and Warnings

GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE 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 ingredient

Avobenzone 2.7% w/v
Octinoxate 6% 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

Do not use  on damaged or broken skin

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 to cleansed lips 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  Limit time in the sun, especially from 10 a.m. - 2 p.m  Wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Drug FactsInactive ingredients

Hydrogenated Polyisobutene, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraisostearate, Glyceryl Rosinate, Octyldodecanol, C30-50 Alcohols, Phenyl Trimethicone, Polyethylene, Titanium Dioxide, Shea (Butyrospermum parkii) Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Phenoxyethanol, Polybutene, Tocopheryl Acetate, Glyceryl Behenate, Sodium Hyaluronate, Octadecyl Di-T-Butyl -4-Hydroxyhydrocinnamate, Iron Oxides*, D&C Red 6*.
* contains one or more of these ingredients.

SPL UNCLASSIFIED SECTION

SPF 15

DELICATE
CHOCOLATE AROMA
VITAMIN E

Manufactured By:
ERKUL COSMETICS San. Tic. A.S.,
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 167 TH
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

GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE 
avobenzone, octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82715-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
GLYCERYL ROSINATE (UNII: SD112V492J)
OCTYLDODECANOL (UNII: 461N1O614Y)
C30-50 ALCOHOLS (UNII: 4MCU204619)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHEA BUTTER (UNII: K49155WL9Y)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: V88J661G2P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 6 (UNII: 481744AI4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82715-108-01	3 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2022

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(82715-108)