SPL v1
SPL
SPL Set ID 8bb05876-d3c4-4fcd-9c56-573471d9c9b0
Route
TOPICAL
Published
Effective Date 2018-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (5.0 g) Titanium Dioxide (4.0 g)
Inactive Ingredients
Water Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-12-01

Description

Active ingredients: Zinc Oxide 10%, Titanium Dioxide 8%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: Hypoallergenic sun cream for children and easily irritated sensitive skin. The natural 100% mineral filter forms a physical barrier to reflect UV light from the surface of the skin. With a skin-friendly moisturizing formula, this sun cream smoothes into the skin easily and protects the skin from external stimuli like fine dust. This mild sun cream is suitable for all skin types, decreases the risk of skin cancer and early skin aging caused by the sun.

Directions:

Apply liberally 15 minutes before sun exposure

Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Questions: www.nislcos.com

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Active Ingredient

Active ingredients: Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredient

Inactive ingredients: Water, Cyclomethicone, Propanediol, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Ethylhexanoate, Aluminum Hydroxide, 1,2-Hexanediol, Disteardimonium Hectorite, Hydrogen Dimethicone, Magnesium Sulfate, Salvia Hispanica Seed Extract, Stearic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone Crosspolymer, Phenyl Trimethicone, Lavandula Angustifolia (Lavender) Oil, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Water, Ethylhexylglycerin, Octyldodecanol, Hydrogenated Lecithin, Echium Plantagineum Seed Oil, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylyl Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Sorbitan Sesquioleate, Cholesterol, Phytosphingosine, Ceramide EOP, Ceramide NS, Ceramide NP, Ceramide AP, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Chamomilla Recutita (Matricaria) Flower Oil, Tocopherol, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Description (DESCRIPTION)

Uses: Hypoallergenic sun cream for children and easily irritated sensitive skin. The natural 100% mineral filter forms a physical barrier to reflect UV light from the surface of the skin. With a skin-friendly moisturizing formula, this sun cream smoothes into the skin easily and protects the skin from external stimuli like fine dust. This mild sun cream is suitable for all skin types, decreases the risk of skin cancer and early skin aging caused by the sun.

Directions:

Apply liberally 15 minutes before sun exposure

Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses

Children under 6 months: Ask a doctor

Questions: www.nislcos.com

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Zinc Oxide 10%, Titanium Dioxide 8%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclomethicone, Propanediol, Dicaprylyl Carbonate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cetyl Ethylhexanoate, Aluminum Hydroxide, 1,2-Hexanediol, Disteardimonium Hectorite, Hydrogen Dimethicone, Magnesium Sulfate, Salvia Hispanica Seed Extract, Stearic Acid, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyglyceryl-2 Dipolyhydroxystearate, Dimethicone Crosspolymer, Phenyl Trimethicone, Lavandula Angustifolia (Lavender) Oil, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Water, Ethylhexylglycerin, Octyldodecanol, Hydrogenated Lecithin, Echium Plantagineum Seed Oil, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylyl Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Sorbitan Sesquioleate, Cholesterol, Phytosphingosine, Ceramide EOP, Ceramide NS, Ceramide NP, Ceramide AP, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Chamomilla Recutita (Matricaria) Flower Oil, Tocopherol, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate

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


Advanced Ingredient Data


Raw Label Data

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