GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE
GOLDEN ROSE TINTED LIP BALM
96efeb92-a276-4ac9-b30a-11b4fa367263
HUMAN OTC DRUG LABEL
Aug 8, 2025
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
Product Classification
Product Specifications
INGREDIENTS (23)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packaging
INDICATIONS & USAGE SECTION
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.
SPL UNCLASSIFIED SECTION
SPF 15
DELICATE
VANILLA 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
Active ingredient
Avobenzone 2.7% w/v
Octinoxate 6% w/v
OTC - PURPOSE SECTION
Purpose
Sunscreen
WARNINGS SECTION
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
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
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
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, Meadowfoam (Limnanthes alba) Seed Oil, Phenoxyethanol,
Polybutene, Tocopheryl Acetate, Glyceryl Behenate, Sodium Hyaluronate,
Octadecyl Di-T-Butyl -4-Hydroxyhydrocinnamate, Iron Oxides*, D&C Red No. 7*.
*contains one or more of these ingredients.