787794a9-6221-427b-9676-3d6e48dd97e1

SPL v1
SPL
SPL Set ID 787794a9-6221-427b-9676-3d6e48dd97e1
Route
topical
Published
Effective Date 2019-05-09
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 2019-03-01

Purpose

Purpose: Sunscreen

Description

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


Medication Information

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.

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.

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, Isononyl Isononanoate, Ethylhexyl Triazone, Glycerin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Sodium Hyaluronate, Biosaccharide Gum-4, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Allantoin, Sorbitan Isostearate, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Polysorbate 80,

Sorbitan Oleate, Xanthan Gum, Sophora Japonica Fruit Extract, Propolis Extract, Pancratium Maritimum Extract, Fomes Officinalis (Mushroom) Extract, Royal Jelly Extract, Honey Extract

Package Label.principal Display Panel


Structured Label Content

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.

Purpose (PURPOSE)

Purpose: Sunscreen

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, Isononyl Isononanoate, Ethylhexyl Triazone, Glycerin, 1,2-Hexanediol, Polyglyceryl-3 Methylglucose Distearate, Sodium Hyaluronate, Biosaccharide Gum-4, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Aluminum Hydroxide, Stearic Acid, Isohexadecane, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, Allantoin, Sorbitan Isostearate, Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Polysorbate 80,

Sorbitan Oleate, Xanthan Gum, Sophora Japonica Fruit Extract, Propolis Extract, Pancratium Maritimum Extract, Fomes Officinalis (Mushroom) Extract, Royal Jelly Extract, Honey Extract

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)