46457c78-74d6-ea6a-e063-6294a90a24ac

SPL v1
SPL
SPL Set ID 46457c78-74d6-ea6a-e063-6294a90a24ac
Route
topical
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (8.463275 g)
Inactive Ingredients
coco-caprylate/caprate sorbitan isostearate methyl methacrylate/glycol dimethacrylate crosspolymer polyglyceryl-6 polyricinoleate isododecane dicaprylyl carbonate polyglyceryl-2 isostearate nymphaea alba flower triethoxycaprylylsilane propanediol water propylheptyl caprylate caprylic/capric triglyceride calcium sodium borosilicate polyglyceryl-2 dipolyhydroxystearate glycerin glyceryl caprylate 1,2-hexanediol cryptomeria japonica leaf nelumbo nucifera leaf magnesium sulfate hydrogenated coconut oil butyloctyl salicylate hectorite tocopherol sodium chloride disteardimonium hectorite caprylyl glycol butylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-01

Purpose

Purpose-​Sunscreen

Description

Active Ingredients-Zinc Oxide 16.9%


Medication Information

Active Ingredient

Active Ingredients-Zinc Oxide 16.9%

Uses

helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Purpose-​Sunscreen

Directions

Directions

apply generously and evenly 15 minutes before sun exposure. apply to all skin exposed to the sun. reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor.

Other Information

Other information protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Inactive ingredients Water, Butyloctyl Salicylate, Propyheptyl Caprylate, Propanediol, Hydrogenated Coco nut Oil, Isodadecane, Caprylic/Capric Triglyceride, Glycerin, Dicaprylyl Carbonate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Fusidium Coccineum Ferment Lysate Extract Filtrate, Nymphaea Alba Flower Extract, Protease, Nelum bo Nicifera Leaf Extract, Sacccharomyces Ferment, Crypto meria Japonica Leaf Extract, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Calcium Sodium Borosilicate, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Coco-Caprylate/Caprate, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Isostearate, Hectorite, Magnesium Sulfate, Butylene Glycol, Tocopherol

Description

Active Ingredients-Zinc Oxide 16.9%

Principal Display Panel

Principal display panel

Warning

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Questions

Question? : Call +82-80-023-1897 (International rates may apply)

Purpose Sunscreen

Purpose-​Sunscreen

Keep Out of Children

* Keep out of Reach of Children. If swallowed, get medical

help or contact a Poison Control Center right away.


Structured Label Content

Active Ingredient (55106-9)

Active Ingredients-Zinc Oxide 16.9%

Uses (USES)

helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Directions

Directions

apply generously and evenly 15 minutes before sun exposure. apply to all skin exposed to the sun. reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor.

Other Information (Other information)

Other information protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Inactive ingredients Water, Butyloctyl Salicylate, Propyheptyl Caprylate, Propanediol, Hydrogenated Coco nut Oil, Isodadecane, Caprylic/Capric Triglyceride, Glycerin, Dicaprylyl Carbonate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Fusidium Coccineum Ferment Lysate Extract Filtrate, Nymphaea Alba Flower Extract, Protease, Nelum bo Nicifera Leaf Extract, Sacccharomyces Ferment, Crypto meria Japonica Leaf Extract, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Calcium Sodium Borosilicate, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Coco-Caprylate/Caprate, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Isostearate, Hectorite, Magnesium Sulfate, Butylene Glycol, Tocopherol

Principal Display Panel (Principal display panel)

Principal display panel

Warning

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Questions

Question? : Call +82-80-023-1897 (International rates may apply)

Purpose Sunscreen (Purpose-Sunscreen)

Purpose-​Sunscreen

Keep Out of Children (Keep Out Of Children)

* Keep out of Reach of Children. If swallowed, get medical

help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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