Egf Uv Shield

Egf Uv Shield
SPL v3
SPL
SPL Set ID 18a533a4-ca50-4f98-a04f-663861cc65bd
Route
TOPICAL
Published
Effective Date 2013-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Zinc Oxide (4.9 g) Titanium Dioxide (4.15 g) Amiloxate (2 g)
Inactive Ingredients
Water Propylene Glycol Cyclomethicone 5 Cyclomethicone 6 Cetyl Peg/ppg-10/1 Dimethicone (hlb 3) Peg-10 Dimethicone (600 Cst) Betaine Disteardimonium Hectorite Magnesium Sulfate, Unspecified Sorbitan Sesquioleate Aluminum Hydroxide Stearic Acid Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Triethoxycaprylylsilane Purslane Poncirus Trifoliata Fruit .alpha.-tocopherol Acetate Sorbitan Isostearate Squalane Jojoba Oil Macadamia Oil Diospyros Kaki Leaf Chinese Cinnamon Artemisia Princeps Leaf Chrysanthellum Indicum Top Chaenomeles Sinensis Fruit Green Tea Leaf Aloe Vera Leaf Chamomile Egg Phospholipids Sorbitol Xanthan Gum Glyceryl Monolinoleate Glyceryl Linolenate Acetyl Hexapeptide-8 Sodium Ascorbate Vitamin A Palmitate Phenoxyethanol Methylparaben Propylparaben Butylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-06-26

Description

Active ingredient Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 4.90% Titanium Dioxide 4.15% Amiloxate 2.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Active ingredient Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 4.90% Titanium Dioxide 4.15% Amiloxate 2.00%

Warning

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin. If sun irritation develops or increases.

When using this product keep out of eyes. Rinse with water to remove.

Drug Fact

Active ingredient

Octinoxate 7.50%

Octisalate 5.00%

Zinc Oxide 4.90%

Titanium Dioxide 4.15%

Amiloxate 2.00%

Egf Uv Shield

EGF UV Shield



Net WT. 2.03 fl. oz(60ml)

Indication & Usage

Directions



Apply generously and evenly 15-20 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply every 1-2 hours after towel drying, swimming or perspiring.

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

Inactive Ingredient

Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance

Dosage & Administration

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures(see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Keep Out of Reach of Children

Stop use and ask a doctor



if rash or irritation develops and lasts.

Keep out of reach of children



if swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Sunscreen

Warning

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin. If sun irritation develops or increases.

When using this product keep out of eyes. Rinse with water to remove.

Drug Fact

Active ingredient

Octinoxate 7.50%

Octisalate 5.00%

Zinc Oxide 4.90%

Titanium Dioxide 4.15%

Amiloxate 2.00%

Egf Uv Shield (EGF UV Shield)

EGF UV Shield



Net WT. 2.03 fl. oz(60ml)

Indication & Usage (Indication & usage)

Directions



Apply generously and evenly 15-20 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply every 1-2 hours after towel drying, swimming or perspiring.

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

Inactive Ingredient (Inactive ingredient)

Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance

Dosage & Administration (Dosage & administration)

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures(see Directions),

decreases the risk of skin cancer and early skin aging caused by the sun.

Keep Out of Reach of Children (Keep out of reach of children)

Stop use and ask a doctor



if rash or irritation develops and lasts.

Keep out of reach of children



if swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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