SPL v1
SPL
SPL Set ID 1bacd250-79b7-40b9-a8bc-3c90964f4ea7
Route
TOPICAL
Published
Effective Date 2021-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.05 g) Homosalate (0.45 g) Octisalate (0.22 g) Titanium Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

Warnings

For external use only. Discontinue use if signs of irritation or rashes appear. Keep out of direct sunlight.

Directions

■ For face, apply gently over your entire skin before sun exposure after your ritual daily moisturization.

Active Ingredients

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

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)

Sunscreen

Warnings (WARNINGS)

For external use only. Discontinue use if signs of irritation or rashes appear. Keep out of direct sunlight.

Directions

■ For face, apply gently over your entire skin before sun exposure after your ritual daily moisturization.

Active Ingredients (ACTIVE INGREDIENTS)

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

Inactive Ingredients (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

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Advanced Ingredient Data


Raw Label Data

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