SPL v1
SPL
SPL Set ID 17ee083d-2cc4-4e0d-8569-0072314b1a33
Route
TOPICAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.84 g) Titanium Dioxide (0.71 g) Zinc Cation (0.58 g) Octisalate (0.54 g)
Inactive Ingredients
Glycerin Diisostearyl Malate

Identifiers & Packaging

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

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.99%, Zinc Oxide 4.91%, Ethylhexyl Salicylate 4.50%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: UV Protection / Whitening / Anti-wrinkle. A cushion compact with ultra light texture that can easily create a radiant complexion. Can be used as a makeup base and/or a highlighter.

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. 4. To use as a highlighter, apply on desired areas such as brow area, nose, cheekbones, forehead and top of the chin. 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: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.99%, Zinc Oxide 4.91%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient

Inactive ingredients: Bambusa Vulgaris Water, Diphenylsiloxy Phenyl Trimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Synthetic Fluorphlogopite, Diisostearyl Malate, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Butylene Glycol, Trimethylsiloxysilicate, Dipropylene Glycol, Mica (CI 77019), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Dimethicone, Fragrance(Parfum), Dimethicone Crosspolymer, Ultramarines (CI 77007), Tin Oxide (CI 77861), Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Biosaccharide Gum-4, Milk Lipids, Pearl Powder, Sucrose Polycottonseedate, Betula Platyphylla Japonica Juice, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Polyglutamic Acid

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: UV Protection / Whitening / Anti-wrinkle. A cushion compact with ultra light texture that can easily create a radiant complexion. Can be used as a makeup base and/or a highlighter.

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. 4. To use as a highlighter, apply on desired areas such as brow area, nose, cheekbones, forehead and top of the chin. 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: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.99%, Zinc Oxide 4.91%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Bambusa Vulgaris Water, Diphenylsiloxy Phenyl Trimethicone, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Synthetic Fluorphlogopite, Diisostearyl Malate, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Butylene Glycol, Trimethylsiloxysilicate, Dipropylene Glycol, Mica (CI 77019), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Dimethicone, Fragrance(Parfum), Dimethicone Crosspolymer, Ultramarines (CI 77007), Tin Oxide (CI 77861), Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disodium EDTA, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Biosaccharide Gum-4, Milk Lipids, Pearl Powder, Sucrose Polycottonseedate, Betula Platyphylla Japonica Juice, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Polyglutamic Acid

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


Advanced Ingredient Data


Raw Label Data

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