Otc - Purpose
Sunscreen
Tirtir Sun Bouncy Glow Lip Balm Spf30 - 04 Burnt Maple Cream
FDA Label NDC 87496-114
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tirtir Usa Inc. for the product Tirtir Sun Bouncy Glow Lip Balm Spf30 - 04 Burnt Maple (NDC 87496-114). 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 otc - purpose, otc - active ingredient, indications & usage, warnings, dosage & administration, otc - stop use, inactive ingredient, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Zinc oxide 13.5%
Indications & Usage
Stop use and ask a doctor if rash occurs.
■ Helps prevent sunburn.
Warnings
For external use only.
Dosage & Administration
Directions
■ Apply liberally 15 minutes before sun exposure.
■ 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.
■ See Outer Package for complete Drug Facts.
■ Children under 6 months of age: Ask a doctor.
Otc - Stop Use
When using this product keep out of eyes. Rinse with water to remove.
Inactive Ingredient
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 - 01 HAZY MAUVE : Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Isononyl Isononanoate, Polyhydroxystearic Acid, Sorbitan Isostearate, VP/Hexadecene Copolymer, Iron Oxides, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, D&C Red No. 7 Calcium Lake, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 - 02 SUNLIT CORAL : Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyhydroxystearic Acid, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides, VP/Hexadecene Copolymer, Isostearic Acid,Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), FD&C Yellow 5 Lake, Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, D&C Red No. 7 Calcium Lake, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 - 03 SOFT SAND : Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyhydroxystearic Acid, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides, VP/Hexadecene Copolymer, Isostearic Acid,Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 - 04 BURNT MAPLE : Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyhydroxystearic Acid, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides, VP/Hexadecene Copolymer, Isostearic Acid,Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38
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.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Otc - Questions
[email protected]
TIRTIR.CO.KR l TIRTIR.GLOBAL
Otc - When Using
How To Use : Apply generously to lips before sun exposure. Reapply at least every 2 hours for optimal protection.
Otc - Do Not Use
Do not use on damaged or broken skin.
* Please review the disclaimer below.
