SPL v1
SPL
SPL Set ID 4c2a472e-7721-41ff-9055-5a692434799c
Route
TOPICAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.15 g) Octinoxate (0.80 g) Octisalate (0.48 g)
Inactive Ingredients
Butylene Glycol Peg-8 Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-01

Description

Active ingredients: Titanium Dioxide 9.66%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: An ultra-light and non-oxidizing cushion foundation that allows layering without caking. Perfect for mid-day touch ups.

Directions: 1. Gently soak the applicator puff on to mesh to use product. 2. Start from inner areas of the face and work outwards 3. Softly swipe over the skin to spread evenly before applying the foundation. * Coverage can build up by layering a small amount several times. 4. Close cap after use. 5. To refill the product: Open outer cap, but close the inner cap and flip over the product. While holding the product push down on the bottom sticker with both thumbs while having outer cap open. Once the existing container is removed, replace it with a refill with the hinge set on the dipped area which is on the left hand side.

Warnings

Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. 4. For external use only.

Active Ingredient

Active ingredients: Titanium Dioxide 9.66%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient

Inactive ingredients: Bambusa Vulgaris Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Butylene Glycol, Glycerin, Niacinamide, Mica (CI 77019), Dimethicone, Iron Oxides (CI 77492), Silica, Cetyl PEG/PPG-10/1 Dimethicone, Dipropylene Glycol, Magnesium Sulfate, Phenoxyethanol, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diphenyl Dimethicone, Fragrance(Parfum), Water, Stearic Acid, Alumina, Disteardimonium Hectorite, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Aluminum Hydroxide, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Calcium Carbonate, Polymethylsilsesquioxane, Gossypium Herbaceum (Cotton) Powder, Caprylic/Capric Triglyceride, Lecithin, Polyglutamic Acid, Cassia Angustifolia Seed Polysaccharide, Phospholipids, Ceramide NP, 1,2-Hexanediol, Cholesterol, Arginine, Phytosterols

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. If any of the following symptoms occur when using the product, stop using immediately and consult a dermatologist. a) red spots, swelling, itchy rashes other skin irritations, etc. b) if a) occurs after applying and being exposed to sunlight. 2. Do not use on wounds, inflamed skin, itchy areas, or other infected areas. 3. Storage and handling: a) must close cap after use. b) Keep out of reach of children. c) keep away from extreme heat, cold and direct sunlight. d) Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water. 4. For external use only.

Description (DESCRIPTION)

Uses: An ultra-light and non-oxidizing cushion foundation that allows layering without caking. Perfect for mid-day touch ups.

Directions: 1. Gently soak the applicator puff on to mesh to use product. 2. Start from inner areas of the face and work outwards 3. Softly swipe over the skin to spread evenly before applying the foundation. * Coverage can build up by layering a small amount several times. 4. Close cap after use. 5. To refill the product: Open outer cap, but close the inner cap and flip over the product. While holding the product push down on the bottom sticker with both thumbs while having outer cap open. Once the existing container is removed, replace it with a refill with the hinge set on the dipped area which is on the left hand side.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 9.66%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Bambusa Vulgaris Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Butylene Glycol, Glycerin, Niacinamide, Mica (CI 77019), Dimethicone, Iron Oxides (CI 77492), Silica, Cetyl PEG/PPG-10/1 Dimethicone, Dipropylene Glycol, Magnesium Sulfate, Phenoxyethanol, Caprylyl Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Diphenyl Dimethicone, Fragrance(Parfum), Water, Stearic Acid, Alumina, Disteardimonium Hectorite, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Aluminum Hydroxide, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Calcium Carbonate, Polymethylsilsesquioxane, Gossypium Herbaceum (Cotton) Powder, Caprylic/Capric Triglyceride, Lecithin, Polyglutamic Acid, Cassia Angustifolia Seed Polysaccharide, Phospholipids, Ceramide NP, 1,2-Hexanediol, Cholesterol, Arginine, Phytosterols

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


Advanced Ingredient Data


Raw Label Data

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