tatcha®

tatcha®
SPL v1
SPL
SPL Set ID fc03c124-c2b3-48ea-a087-4d956e77eaf7
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)