SPL v1
SPL
SPL Set ID 11739ce7-c657-4593-a1a6-a9d747860ab4
Route
TOPICAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5 g) Octocrylene (2.5 g) Octisalate (2.25 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

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

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Octocrylene 5.00%, Ethylhexyl Salicylate 4.50%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: A cooling and moisturizing UV protector/makeup primer. When applied, it protects the skin from UV rays and leaves a beautiful sheen. Contains internationally renowned Korean Jeju hypoxic water and British Harrogate sparkling water.

Directions: Pump appropriate amount of the product onto your hands and apply on the entire face in outward strokes using a sponge or fingertips. If required, reapply it on areas that are vulnerable to sunlight such as cheekbones, nasal bridge, and forehead. Close cap after use.

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%, Octocrylene 5.00%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient

Inactive ingredients: Water, Alcohol Denat., Butylene Glycol, Butyl Methoxydibenzoylmethane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica, Methyl Methacrylate Crosspolymer, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Fragrance, Isohexadecane, Caprylyl Glycol, Potassium Hydroxide, Polysorbate 80, Phenoxyethanol, 1,2-Hexanediol, Ethylhexylglycerin, BHT, Citrus Aurantifolia (Lime) Oil, Disodium EDTA, Buddleja Axillaris Leaf Extract, Phyllostachis Bambusoides Juice, Malpighia Emarginata (Acerola) Fruit Extract, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sorbaria Sorbifolia Bark/Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Carex Humillis Root Extract, Nelumbo Nucifera Flower Extract, Lilium Candidum Bulb Extract, Alcohol, Syringa Vulgaris (Lilac) Extract, Glycine, Serine, Glutamic Acid, Saussurea Involucrata Extract, Aspartic acid, Leucine, Camellia Sinensis Leaf Extract, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Aloe Barbadensis Leaf Extract, Psidium Guajava Leaf Extract, Abronia Villosa Leaf Extract, Cinchona Succirubra Bark Extract, Chenopodium Quinoa Seed Extract, Histidine, Methionine, Cysteine, Rhodiola Rosea Root Extract, Oxygen

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: A cooling and moisturizing UV protector/makeup primer. When applied, it protects the skin from UV rays and leaves a beautiful sheen. Contains internationally renowned Korean Jeju hypoxic water and British Harrogate sparkling water.

Directions: Pump appropriate amount of the product onto your hands and apply on the entire face in outward strokes using a sponge or fingertips. If required, reapply it on areas that are vulnerable to sunlight such as cheekbones, nasal bridge, and forehead. Close cap after use.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Octocrylene 5.00%, Ethylhexyl Salicylate 4.50%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Alcohol Denat., Butylene Glycol, Butyl Methoxydibenzoylmethane, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Silica, Methyl Methacrylate Crosspolymer, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate, Crosspolymer, Fragrance, Isohexadecane, Caprylyl Glycol, Potassium Hydroxide, Polysorbate 80, Phenoxyethanol, 1,2-Hexanediol, Ethylhexylglycerin, BHT, Citrus Aurantifolia (Lime) Oil, Disodium EDTA, Buddleja Axillaris Leaf Extract, Phyllostachis Bambusoides Juice, Malpighia Emarginata (Acerola) Fruit Extract, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sorbaria Sorbifolia Bark/Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Carex Humillis Root Extract, Nelumbo Nucifera Flower Extract, Lilium Candidum Bulb Extract, Alcohol, Syringa Vulgaris (Lilac) Extract, Glycine, Serine, Glutamic Acid, Saussurea Involucrata Extract, Aspartic acid, Leucine, Camellia Sinensis Leaf Extract, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Aloe Barbadensis Leaf Extract, Psidium Guajava Leaf Extract, Abronia Villosa Leaf Extract, Cinchona Succirubra Bark Extract, Chenopodium Quinoa Seed Extract, Histidine, Methionine, Cysteine, Rhodiola Rosea Root Extract, Oxygen

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


Advanced Ingredient Data


Raw Label Data

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