FDA.reportPublic FDA data

TIRTIR SUN BOUNCE GLOW LIP BALM SPF 30 SOFT SAND

Manufacturer
COSMAX USA
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:02

Label at a glance#

ProductTIRTIR SUN BOUNCE GLOW LIP BALM SPF 30 SOFT SAND
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Uses Helps prevent sunburn

Dosage and 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 you 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, ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc oxide 13.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 you 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
  • Children under 6 months of age: Ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information

Protect the product in this container from excessive heat and direct sun.

QUESTIONS

OTC - QUESTIONS SECTION

Questions?cs@tirtir.global TIRTIR.CO.KR / TIRTIR.GLOBAL

INACTIVE INGREDIENT SECTION

Inactive IngredientsDiisostearyl 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-24168577-241-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE1K09F3G675IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
WATER059QF0KO0RIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SORBITAN OLIVATEMDL271E3GRIACT
SUCROSE COCOATE3H18P0UK73IACT
ALCOHOL3K9958V90MIACT
PALMITOYL TRIPEPTIDE-38T7A529FB8OIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
HYALURONIC ACIDS270N0TRQYIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ROSA CANINA SEED OILMHT97MG5P8IACT
MANGIFERA INDICA (MANGO) SEED BUTTER4OXD9M35X2IACT
HYDROGENATED POLYISOBUTENE (450 MW)7YR4ZFS62EIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
PORTULACA PILOSA WHOLEII29C6E5R3IACT
TOCOPHEROLR0ZB2556P8IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
CETEARYL ETHYLHEXANOATE9M64UO4C25IACT
DEHYDROACETIC ACID2KAG279R6RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4d31ee91-cd9a-6e2b-e063-6294a90a428c4c299fe7-fa0b-1f9f-e063-6294a90ae7342026-03-17WarningsExact identifier
spl set id: 4c299fe7-fa0b-1f9f-e063-6294a90ae734

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.