SPL v1
SPL
SPL Set ID 943e9f7f-ec0e-483a-9171-0cd64f93618c
Route
TOPICAL
Published
Effective Date 2019-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3.80 g) Octocrylene (2.00 g) Octisalate (1.80 g) Avobenzone (1.20 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-12-01

Description

Active ingredients: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

A cooling and moisturizing UV protector / makeup primer.

Aqua UV cooling protector provides the skin with protection from UV rays and the unique aqua base formula creates a moisturizing, cooling and refreshing effect.

Directions:

Pump appropriate amount of the product onto your hands and apply on the entire face in outward strokes using a sponge or fingertips. 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: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient

Inactive Ingredient:

Water, Alcohol Denat., Butylene Glycol, Acrylates Copolymer, Diphenylsiloxy Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Polymethylsilsesquioxane, "Sodium Acrylate/Sodium Acryloyldimethyl, Taurate Copolymer", Isohexadecane, Beheneth-25, Caprylyl Glycol, Fragrance(Parfum), Polysorbate 80, Sorbitan Oleate, Disodium EDTA, Saccharide Isomerate, Xylitylglucoside, Anhydroxylitol, Xylitol, Glucose, Citric Acid, Sodium Citrate

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.

Aqua UV cooling protector provides the skin with protection from UV rays and the unique aqua base formula creates a moisturizing, cooling and refreshing effect.

Directions:

Pump appropriate amount of the product onto your hands and apply on the entire face in outward strokes using a sponge or fingertips. Close cap after use.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Homosalate 9.5%, Octocrylene 5.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredient:

Water, Alcohol Denat., Butylene Glycol, Acrylates Copolymer, Diphenylsiloxy Phenyl Trimethicone, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Polymethylsilsesquioxane, "Sodium Acrylate/Sodium Acryloyldimethyl, Taurate Copolymer", Isohexadecane, Beheneth-25, Caprylyl Glycol, Fragrance(Parfum), Polysorbate 80, Sorbitan Oleate, Disodium EDTA, Saccharide Isomerate, Xylitylglucoside, Anhydroxylitol, Xylitol, Glucose, Citric Acid, Sodium Citrate

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


Advanced Ingredient Data


Raw Label Data

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