SPL v1
SPL
SPL Set ID 77671c32-f8c1-47be-8ebc-209a51962c3e
Route
TOPICAL
Published
Effective Date 2018-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.50 g) Homosalate (3.00 g) Octisalate (2.25 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

Containing the UV suncare secret of Village 11 Factory, this moist uv block sun fluid absorbs into your skin immediately without any stickiness. Also, it helps to prevent sunburn.

Directions:

For the last step of your skin care, apply an appropriate amount onto areas of your skin that is exposed to sunlight.

Warnings

Warnings:

1) In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

2) Do not apply on broken skin or wounded areas.

3) Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight.

4) For external use only

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient

Inactive ingredients:

Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol, Alcohol,Methyl Methacrylate Crosspolymer,Niacinamide 1,2-Hexanediol,Polymethylsilsesquioxane, Salvia HispanicaSeed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Ethylhexylglycerin,Xanthan Gum, Octyldodecanol, Adenosine, EchiumPlantagineum Seed Oil, Butylene Glycol,Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) SeedOil Unsaponifiables, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, GlycerylStearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, TitaniumDioxide (CI 77891), C12-15 Alkyl Benzoate, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, CinnamomumCassia Bark Extract, Scutellaria Baicalensis Root Extract, Tocopherol,Moringa Pterygosperma Seed Extract, Polyglyceryl-2 Caprate,Aluminum Stearate, Polyhydroxystearic Acid, Alumina,Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol,Stearic Acid, Glyceryl Caprylate, Squalane,Fragrance

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

1) In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

2) Do not apply on broken skin or wounded areas.

3) Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight.

4) For external use only

Description (DESCRIPTION)

Uses:

Containing the UV suncare secret of Village 11 Factory, this moist uv block sun fluid absorbs into your skin immediately without any stickiness. Also, it helps to prevent sunburn.

Directions:

For the last step of your skin care, apply an appropriate amount onto areas of your skin that is exposed to sunlight.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Glycerin, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol, Alcohol,Methyl Methacrylate Crosspolymer,Niacinamide 1,2-Hexanediol,Polymethylsilsesquioxane, Salvia HispanicaSeed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Ethylhexylglycerin,Xanthan Gum, Octyldodecanol, Adenosine, EchiumPlantagineum Seed Oil, Butylene Glycol,Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) SeedOil Unsaponifiables, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, GlycerylStearate, Dimethicone, Carbomer, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 20, Polyacrylate Crosspolymer-6, TitaniumDioxide (CI 77891), C12-15 Alkyl Benzoate, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, CinnamomumCassia Bark Extract, Scutellaria Baicalensis Root Extract, Tocopherol,Moringa Pterygosperma Seed Extract, Polyglyceryl-2 Caprate,Aluminum Stearate, Polyhydroxystearic Acid, Alumina,Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, t-Butyl Alcohol,Stearic Acid, Glyceryl Caprylate, Squalane,Fragrance

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)