SPL v1
SPL
SPL Set ID e1f988a3-98b3-4e86-81eb-a089dfb14cfb
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 Niacinamide

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 daily mild sun cream is strong against UV rays but is gentle on the skin. 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,n Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol,Niacinamide, Cyclopentasiloxane,1,2-Hexanediol, Glyceryl Stearate, C12-15 Alkyl Benzoate,PEG-100 Stearate, Titanium Dioxide (CI77891), Salvia Hispanica Seed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Polysorbate 60, AmmoniumAcryloyldimethyltaurate/VP Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl MethacrylateCrosspolymer, Squalane,Fructooligosaccharides, Saccharide Hydrolysate, Aluminum Stearate, Polyhydroxystearic Acid, Pullulan,Ethylhexylglycerin, Octyldodecanol, Portulaca Oleracea Extract, Adenosine, Alumina,Butylene Glycol, Disodium EDTA, SorbitanIsostearate, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower)Seed Oil Unsaponifiables, Tocopherol, 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 daily mild sun cream is strong against UV rays but is gentle on the skin. 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,n Diethylamino Hydroxybenzoyl Hexyl Benzoate, Propanediol,Niacinamide, Cyclopentasiloxane,1,2-Hexanediol, Glyceryl Stearate, C12-15 Alkyl Benzoate,PEG-100 Stearate, Titanium Dioxide (CI77891), Salvia Hispanica Seed Extract, Centella Asiatica Extract,Houttuynia Cordata Extract, Polysorbate 60, AmmoniumAcryloyldimethyltaurate/VP Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methyl MethacrylateCrosspolymer, Squalane,Fructooligosaccharides, Saccharide Hydrolysate, Aluminum Stearate, Polyhydroxystearic Acid, Pullulan,Ethylhexylglycerin, Octyldodecanol, Portulaca Oleracea Extract, Adenosine, Alumina,Butylene Glycol, Disodium EDTA, SorbitanIsostearate, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower)Seed Oil Unsaponifiables, Tocopherol, Fragrance

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


Advanced Ingredient Data


Raw Label Data

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