GR LIP BUTTER COOKIE SPF 15- avobenzone, octinoxate lipstick

GR LIP BUTTER COOKIE SPF 15 by

Drug Labeling and Warnings

GR LIP BUTTER COOKIE 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 ingredient

Avobenzone 2.7% w/w
Octinoxate 6% w/w

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.

Inactive Ingredients

Ppg-3 Hydrogenated Castor Oil, Neopentyl Glycol Diheptanoate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Synthetic Wax, Astrocaryum Murumuru Seed Butter, Theobroma Grandiflorum Seed Butter, Caprylyl Glycol, Tocopheryl Acetate, Flavor, Octadecyl Di-T-Butyl-4-Hydroxyhydrocinnamate, Phenoxyethanol, *Titanium Dioxide, *Iron Oxides,*Yellow 5 *contains one or more of these ingredients.

SPL UNCLASSIFIED SECTION

Vitamin E

Keeps lips soft and smooth.

Cute shape

Easy to use.

Lip Butter with Cookie Flavour contains Cupuacu, Murumuru and Shea Butter to feel lips softened and hydrated.

DERMATOLOGICALLY TESTED

Manufactured By:
ERKUL COSMETICS San. Tic. A.S.,
P.Ofisi Cd. 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 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

GR LIP BUTTER COOKIE SPF 15 
avobenzone, octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82715-119
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 CASTOR OIL (UNII: ZF94AP8MEY)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE (UNII: V88J661G2P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82715-119-01	1 in 1 BOX	10/25/2023
1		8 g 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 Drug	M020	10/25/2023

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(82715-119)