SPL v1
SPL
SPL Set ID d218a8de-e996-4e5e-a931-b29017909b78
Route
TOPICAL
Published
Effective Date 2021-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 g) Octisalate (2.0 g)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-07-01

Description

Ethylhexyl Methoxycinnamate 7.0% Ethylhexyl Salicylate 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ethylhexyl Methoxycinnamate 7.0% Ethylhexyl Salicylate 4.0%

Uses

■ helps prevent sunburn

■ it 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

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 product is swallowed, get medical help or contact a Posion Control Center right away

Questions

www.byselected.co.kr

[email protected]

+82-70-8883-2525

Directions

■ Apply liberally and spread evenly by hand 15 minutes before sun exposure•reapply:•after 80 minutes of swimming or sweating•immediately after towel drying • 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 docto

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Active Ingredients

Ethylhexyl Methoxycinnamate 7.0%

Ethylhexyl Salicylate 4.0%

Inactive Ingredients

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dipropylene Glycol, Butylene Glycol, Ethylhexyl Palmitate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Dibutyl Adipate, Ethylhexyl Triazone, Glyceryl Stearate, Hexyl Laurate,  olyglyceryl-3 Methylglucose Distearate, Polysorbate 60, C14-22 Alcohols, PEG-100 Stearate, 1,2-Hexanediol, Limonia Acidissima Extract, Hydroxyacetophenone, Silica, Fragrance, C12-20 Alkyl Glucoside, Carbomer, Dimethicone, Tromethamine, Ophiopogon Japonicus Root  Extract, Panax Ginseng Root Extract, Schisandra Chinensis Fruit Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Disodium EDTA, 

Ipomoea Purpurea Extract, Lilium Candidum Flower Extract, Magnolia Liliflora Flower Extract, Paeonia Albiflora Flower Extract

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Posion Control Center right away

Package Label.principal Display Panel


Structured Label Content

Uses

■ helps prevent sunburn

■ it 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 (PURPOSE)

Sunscreen

Warnings (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 product is swallowed, get medical help or contact a Posion Control Center right away

Questions

www.byselected.co.kr

[email protected]

+82-70-8883-2525

Directions

■ Apply liberally and spread evenly by hand 15 minutes before sun exposure•reapply:•after 80 minutes of swimming or sweating•immediately after towel drying • 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 docto

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Active Ingredients (ACTIVE INGREDIENTS)

Ethylhexyl Methoxycinnamate 7.0%

Ethylhexyl Salicylate 4.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dipropylene Glycol, Butylene Glycol, Ethylhexyl Palmitate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Dibutyl Adipate, Ethylhexyl Triazone, Glyceryl Stearate, Hexyl Laurate,  olyglyceryl-3 Methylglucose Distearate, Polysorbate 60, C14-22 Alcohols, PEG-100 Stearate, 1,2-Hexanediol, Limonia Acidissima Extract, Hydroxyacetophenone, Silica, Fragrance, C12-20 Alkyl Glucoside, Carbomer, Dimethicone, Tromethamine, Ophiopogon Japonicus Root  Extract, Panax Ginseng Root Extract, Schisandra Chinensis Fruit Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Disodium EDTA, 

Ipomoea Purpurea Extract, Lilium Candidum Flower Extract, Magnolia Liliflora Flower Extract, Paeonia Albiflora Flower Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If product is swallowed, get medical help or contact a Posion Control Center right away

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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