SPL v1
SPL
SPL Set ID b0573b65-7ce0-4aca-bc66-c41d1d00d48e
Route
TOPICAL
Published
Effective Date 2016-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.67 g) Titanium Dioxide (0.77 g) Octisalate (0.45 g) Zinc Cation (0.31 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-12-01

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 8.65755%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.52%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 8.65755%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.52%

Warnings

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

How to Use

How to use: Once an appropriate amount has accumulated, use the included puff to smooth it out onto your face by patting it in an outward motion.

Active Ingredient

Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 8.65755%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.52%

Inactive Ingredient

AGATHA FITTING TOUCH MAKE UP FOUNDATION PACT - Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Trimethylsiloxysilicate, Phenyl Trimethicone, Glycerin, Niacinamide, Diglycerin, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane, Disteardimonium Hectorite, Diisostearyl Malate, Sodium Chloride, Sorbitan Sesquioleate, Helianthus Annuus (Sunflower) Seed Oil, Oenothera Biennis(Evening Primrose) Oil, Anthemis Nobilis Flower Water, Rosa Damascena Flower Water, Panax Ginseng Root Extract, Tocopherol, Centella Asiatica Extract, Sodium Hyaluronate, Olea Europaea(Olive) Fruit Oil, Lecithin, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Phytosterols, Squalane, Hydrolyzed Collagen, Tocopheryl Acetate, Paeonia Lactiflora Root Extract, Hydrolyzed Pea Protein, Saussurea Involucrata Extract, Citrus Aurantium Dulcis(Orange) Flower Extract, Dioscorea Japonica Root Extract, Plumeria Rubra Flower Extract, Tremella Fuciformis (Mushroom) Extract, Butyrospermum Parkii(Shea Butter), Ceramide 3, Mica(CI77019), Polymethyl Methacrylate, Aluminum Hydroxide, Ozokerite, Polyhydroxystearic Acid, Dimethicone, Stearic Acid, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Disodium EDTA, Adenosine, Linoleic Acid, Phenoxyethanol, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides(CI77492), Iron Oxides(CI77491), Iron Oxides(CI77499), Fragrance

AGATHA TINTED LIP GLOW - Ingredients: Diisostearyl Malate, Limnanthes Alba(Meadowfoam) Seed Oil, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Methyl Hydrogenated Rosinate, Hydrogenated Castor Oil Dimer Dilinoleate, Synthetic Fluorphlogopite, Hydrogenated Vegetable Oil, Astrocaryum Murumuru seed Butter, Euphorbia Cerifera(Candelilla) Wax, Polyethylene, Butyrospermum Parkii(Shea Butter), Tocopheryl Acetate, Ceresin, Ethylene/Propylene Copolymer, Synthetic Wax, Copernicia Cerifera(Carnauba) Wax, Sucrose Tetrastearate Triacetate, Triethoxycaprylylsilane, Fragrance, Red 27 (CI45410:1)

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

How to Use (How to use)

How to use: Once an appropriate amount has accumulated, use the included puff to smooth it out onto your face by patting it in an outward motion.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Ethylhexyl Methoxycinnamate 7.5%, Titanium Dioxide 8.65755%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 3.52%

Inactive Ingredient (INACTIVE INGREDIENT)

AGATHA FITTING TOUCH MAKE UP FOUNDATION PACT - Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, PEG-10 Dimethicone, Trimethylsiloxysilicate, Phenyl Trimethicone, Glycerin, Niacinamide, Diglycerin, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane, Disteardimonium Hectorite, Diisostearyl Malate, Sodium Chloride, Sorbitan Sesquioleate, Helianthus Annuus (Sunflower) Seed Oil, Oenothera Biennis(Evening Primrose) Oil, Anthemis Nobilis Flower Water, Rosa Damascena Flower Water, Panax Ginseng Root Extract, Tocopherol, Centella Asiatica Extract, Sodium Hyaluronate, Olea Europaea(Olive) Fruit Oil, Lecithin, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Convallaria Majalis Bulb/Root Extract, Magnolia Liliflora Flower Extract, Phytosterols, Squalane, Hydrolyzed Collagen, Tocopheryl Acetate, Paeonia Lactiflora Root Extract, Hydrolyzed Pea Protein, Saussurea Involucrata Extract, Citrus Aurantium Dulcis(Orange) Flower Extract, Dioscorea Japonica Root Extract, Plumeria Rubra Flower Extract, Tremella Fuciformis (Mushroom) Extract, Butyrospermum Parkii(Shea Butter), Ceramide 3, Mica(CI77019), Polymethyl Methacrylate, Aluminum Hydroxide, Ozokerite, Polyhydroxystearic Acid, Dimethicone, Stearic Acid, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Disodium EDTA, Adenosine, Linoleic Acid, Phenoxyethanol, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides(CI77492), Iron Oxides(CI77491), Iron Oxides(CI77499), Fragrance

AGATHA TINTED LIP GLOW - Ingredients: Diisostearyl Malate, Limnanthes Alba(Meadowfoam) Seed Oil, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Methyl Hydrogenated Rosinate, Hydrogenated Castor Oil Dimer Dilinoleate, Synthetic Fluorphlogopite, Hydrogenated Vegetable Oil, Astrocaryum Murumuru seed Butter, Euphorbia Cerifera(Candelilla) Wax, Polyethylene, Butyrospermum Parkii(Shea Butter), Tocopheryl Acetate, Ceresin, Ethylene/Propylene Copolymer, Synthetic Wax, Copernicia Cerifera(Carnauba) Wax, Sucrose Tetrastearate Triacetate, Triethoxycaprylylsilane, Fragrance, Red 27 (CI45410:1)

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


Advanced Ingredient Data


Raw Label Data

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