Egf Uv Shield

Egf Uv Shield
SPL v2
SPL
SPL Set ID 705f9494-f60b-f5fb-e053-2991aa0adda4
Route
TOPICAL
Published
Effective Date 2018-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Zinc Oxide (0.9 g) Titanium Dioxide (4.15 g) Amiloxate (2 g)
Inactive Ingredients
Water Triepoxycyclohexasilane

Identifiers & Packaging

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

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%

Section 51945-4

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%

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, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance

Dosage & Administration

for external use only

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

Section 51945-4 (51945-4)

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%

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, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance

Dosage & Administration (Dosage & administration)

for external use only

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

All Sections (JSON)