Golden Rose Glow Kiss Tinted Lip Balm Choco Cake Lipstick
FDA Label NDC 82715-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi for the product Golden Rose Glow Kiss Tinted Lip Balm Choco Cake (NDC 82715-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Keep Out Of Reach Of Children
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.
Packaging
Choco Cake-01 (82715 108 03)
* Please review the disclaimer below.
