SPL v1
SPL
SPL Set ID 789d6e73-0a0d-43e2-a69f-d5c9732805c1
Route
TOPICAL
Published
Effective Date 2020-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.50 g) Homosalate (1.50 g) Octisalate (0.74 g) Titanium Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses

■ Helps prevent skin from excessive exposure to UV rays

■ Helps moisturize and refresh your skin that is easy to be dehydrated under the sun for long hours

■ Provides a gentle application without greasy or sticky feeling

Directions

■ For face, apply a dime-sized amount liberally and gently over your entire skin before sun exposure after your ritual daily moisturization.

■ For body, apply liberally and uniformly to any exposed areas of your body before sun exposure or long-hour outdoor activities to ensure sun protection.

Warnings

Warnings:

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep out of reach of children. Keep out of direct sunlight.

Active Ingredient

Active ingredients:

Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

Inactive Ingredient

Inactive ingredients:

Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, 1,2-Hexanediol, Glycerin, Isononyl Isononanoate, Ethylhexyl Triazone, Polyglyceryl-3 Methylglucose Distearate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclopentasiloxane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Xanthan Gum, Tocopheryl Acetate, Sorbitan Isostearate, Ethylhexylglycerin, Allantoin, Limonene, Polysorbate 80, Sorbitan Oleate, Butylene Glycol, Citrus Limon (Lemon) Peel Oil, Sodium Hyaluronate, Rosa Damascena Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Camellia Japonica Flower Extract, Citral, Honey Extract, Propolis Extract, Royal Jelly Extract, Sophora Japonica Fruit Extract, Ethyl Hexanediol, Lavandula Angustifolia (Lavender) Flower Extract, Viola Tricolor Extract, Centaurea Cyanus Flower Extract, Pancratium Maritimum Extract, Caprylyl Glycol

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. If any adverse reaction occurs, stop using the product and consult with dermatologist if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use. Keep out of reach of children. Keep out of direct sunlight.

Description (DESCRIPTION)

Uses

■ Helps prevent skin from excessive exposure to UV rays

■ Helps moisturize and refresh your skin that is easy to be dehydrated under the sun for long hours

■ Provides a gentle application without greasy or sticky feeling

Directions

■ For face, apply a dime-sized amount liberally and gently over your entire skin before sun exposure after your ritual daily moisturization.

■ For body, apply liberally and uniformly to any exposed areas of your body before sun exposure or long-hour outdoor activities to ensure sun protection.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients:

Ethylhexyl Methoxycinnamate 7.0%, Homosalate 3.0%, Ethylhexyl Salicylate 3.0%, Titanium Dioxide 1.49%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Alcohol, Pentylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, 1,2-Hexanediol, Glycerin, Isononyl Isononanoate, Ethylhexyl Triazone, Polyglyceryl-3 Methylglucose Distearate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cyclopentasiloxane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Xanthan Gum, Tocopheryl Acetate, Sorbitan Isostearate, Ethylhexylglycerin, Allantoin, Limonene, Polysorbate 80, Sorbitan Oleate, Butylene Glycol, Citrus Limon (Lemon) Peel Oil, Sodium Hyaluronate, Rosa Damascena Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Camellia Japonica Flower Extract, Citral, Honey Extract, Propolis Extract, Royal Jelly Extract, Sophora Japonica Fruit Extract, Ethyl Hexanediol, Lavandula Angustifolia (Lavender) Flower Extract, Viola Tricolor Extract, Centaurea Cyanus Flower Extract, Pancratium Maritimum Extract, Caprylyl Glycol

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


Advanced Ingredient Data


Raw Label Data

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