MedPath

GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICE

GOLDEN ROSE TINTED LIP BALM

Approved
Approval ID

6cdb0b61-a9c2-4a78-9752-8e7aedaeef45

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 8, 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.

Avobenzone, Octinoxate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82715-113
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Octinoxate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 8, 2025
FDA Product Classification

INGREDIENTS (21)

AVOBENZONEActive
Quantity: 2.7 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
OCTINOXATEActive
Quantity: 6 g in 100 g
Code: 4Y5P7MUD51
Classification: ACTIB
HYDROGENATED POLYBUTENE (1300 MW)Inactive
Code: 7D1YQ9Y5EZ
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PENTAERYTHRITYL TETRAISOSTEARATEInactive
Code: 9D7IK5483F
Classification: IACT
GLYCERYL ROSINATEInactive
Code: SD112V492J
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
C30-50 ALCOHOLSInactive
Code: 4MCU204619
Classification: IACT
PHENYL TRIMETHICONEInactive
Code: DR0K5NOJ4R
Classification: IACT
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
MEADOWFOAM SEED OILInactive
Code: 412ZHA4T4Y
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
GLYCERYL MONOBEHENATEInactive
Code: A626UU0W2A
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
OCTADECYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATEInactive
Code: V88J661G2P
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
D&C RED NO. 6Inactive
Code: 481744AI4O
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/29/2022

Packaging

ERKUL-113

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/29/2022

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

SPF 15

DELICATE
CHERRY 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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/28/2022

Active ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/28/2022

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/29/2022

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/29/2022

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/29/2022

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: 7/28/2022

Drug Facts

Inactive 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, D&C Red 7/ D&C Red 6*.

  • contains one or more of these ingredients.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.