FDA.reportPublic FDA data

TATCHA THE KISSU LIP TINT SPF 25 CAMELLIA

Manufacturer
TATCHA INC.
Effective date
2024-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:40

Label at a glance#

ProductTATCHA THE KISSU LIP TINT SPF 25 CAMELLIA
Active ingredientOCTISALATE, ZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • 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 of 15 or higher and other sun protection measures including: • Limit time in the sun, especia...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 4.7%
Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

TRIETHYLHEXANOIN, DIISOSTEARYL MALATE, SYNTHETIC WAX, POLYBUTENE, GLYCERYL DIISOSTEARATE, CANDELILLA CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX/CIRE DE CANDELILLA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, GLYCERYL DIISOSTEARATE/HYDROGENATED ROSINATE, HYDROLYZED SILK, TOCOPHEROL, SILICA. MAY CONTAIN [+/-]: RED 30 LAKE (CI 73360), YELLOW 5 LAKE (CI 19140), IRON OXIDES (CI 77499), TITANIUM DIOXIDE (CI 77891)

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

1 877 322-8633

SPL UNCLASSIFIED SECTION

broad spectrum SPF 25 sunscreen

A creamy lip tint with buildable color that protects against UVA/UVB rays with SPF 25 while locking in moisture for soft, comfortable lips.

MADE IN JAPAN

DIST. TATCHA LLC
SAN FRANCISCO, CA 94123 USA
UK: Delphic HSE GU14 7NA
NL: 104 Schiphol, 1118CN
© 2024 TATCHA LLC


TATCHA.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAMELLIACAMELLIA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69417-160-01TATCHA THE KISSU LIP TINT SPF 25 CAMELLIA4 g in 1 TUBELIPSTICK41
69417-160-01TATCHA THE KISSU LIP TINT SPF 25 CAMELLIA1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69417-160TATCHA THE KISSU LIP TINT SPF 25 CAMELLIA (OCTISALATE, ZINC OXIDE) LIPSTICK [TATCHA INC.]12 package rows20240405_fc03c124-c2b3-48ea-a087-4d956e77eaf7.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69417-16069417-160-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
TRIETHYLHEXANOIN7K3W1BIU6KIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
PARAFFINI9O0E3H2ZEIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
GLYCERYL DIISOSTEARATE68BAV42LRCIACT
CANDELILLA WAXWL0328HX19IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TOCOPHEROLR0ZB2556P8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 302S42T2808BCNTM
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7CNTM
FERROSOFERRIC OXIDEXM0M87F357CNTM
TITANIUM DIOXIDE15FIX9V2JPCNTM

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
TATCHA THE KISSU LIP TINT SPF 25 CAMELLIAOCTISALATE, ZINC OXIDETATCHA INC.fc03c124-c2b3-48ea-a087-4d956e77eaf72024-02-17WarningsExact identifier
ndc (package): 69417-160-01
ndc (product): 69417-160
ndc11 (package): 69417016001
spl id: 0b131ab7-ff1d-4ce2-930f-2ecbcc41c3d1
spl set id: fc03c124-c2b3-48ea-a087-4d956e77eaf7

Reported adverse events (FAERS/openFDA)#

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