tatcha®

tatcha®
SPL v1
SPL
SPL Set ID 4e267589-8c40-467d-a3df-fc0eeeab0444
Route
topical
Published
Effective Date 2024-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.7 g) zinc oxide (15 g)
Inactive Ingredients
triethylhexanoin diisostearyl malate paraffin polybutene (1400 mw) glyceryl diisostearate candelilla wax ethylhexylglycerin phenoxyethanol tocopherol silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-12

Purpose

Sunscreen

Description

Octisalate 4.7% Zinc Oxide 15%


Medication Information

Warnings

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.

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.

Purpose

Sunscreen

Directions

• 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.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

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)

Description

Octisalate 4.7% Zinc Oxide 15%

Questions?

1 877 322-8633

Section 42229-5

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

Section 50565-1

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

Packaging

Drug Facts

Active Ingredients

Octisalate 4.7%

Zinc Oxide 15%


Structured Label Content

Warnings

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.

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.

Purpose

Sunscreen

Directions

• 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.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

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)

Questions?

1 877 322-8633

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredients

Octisalate 4.7%

Zinc Oxide 15%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)