Advanced Anti-aging Eye Cream

Advanced Anti-aging Eye Cream
SPL v9
SPL
SPL Set ID f4234ac9-7980-40ca-b581-bea08453d486
Route
TOPICAL
Published
Effective Date 2013-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Zinc Oxide (10.1 mg)
Inactive Ingredients
Water Ethylhexyl Stearate Cyclomethicone 5 Propanediol Butylene Glycol Alkyl (c12-15) Benzoate Potassium Cetyl Phosphate Isohexadecane Cetostearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Mica Phenoxyethanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Imperata Cylindrica Root Titanium Dioxide Polyoxyl 20 Cetostearyl Ether Squalane Glycerin Triethoxycaprylylsilane Xanthan Gum Sunflower Oil Polysorbate 60 Trisodium Ethylenediamine Disuccinate Chlorphenesin Citric Acid Monohydrate Dimethicone Glycyrrhizinate Dipotassium Ethylhexylglycerin Oleth-3 Phosphate Polyethylene Glycol 400 Punica Granatum Seed Oil Safflower Oil Silicon Dioxide Green Tea Leaf Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Black Olive Methylisothiazolinone Tocotrienols Lauroyl Lysine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-02

Description

Active Ingredients Purpose Octinoxate 7.5% Sunscreen Zinc Oxide 10.1% Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin.

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions Apply Liberally 15 minutes before sun exposure

Use a water resistant if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor



Sun Protection Measures

Spending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.-2p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Description

Active Ingredients Purpose Octinoxate 7.5% Sunscreen Zinc Oxide 10.1% Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mica, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Imperata Cylindrica Root Extract, Titanium Dioxide, Ceteareth-20, Squalane, Glycerin, Triethoxycaprylylsilane, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Trisodium Ethylene Disuccinate, Chlorphenesin, Citric Acid, Dimethicone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Oleth-3 Phosphate, PEG-8, Punica Granatum Seed Oil, Avena Sativa (Oat) Peptide, Silica, Camellia Sinensis Leaf Extract, Carbomer, Olea Europaea (Olive) Fruit Extract, Euterpe Oleracea Fruit Extract, Methylisothiazolinone, Tocotrienols, Lauroyl Lysine.

Section 51945-4



Advanced Anti-Aging Eye Cream Broad Spectrum SPF 37

Wrinkle-reducing oat peptide complex

Supergoop!

Opthamologist tested for sensitive eye area.

0.5 fl. oz./15 ml.

Section 55105-1

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

Section 55106-9

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.1% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions Apply Liberally 15 minutes before sun exposure

Use a water resistant if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor



Sun Protection Measures

Spending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m.-2p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mica, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Imperata Cylindrica Root Extract, Titanium Dioxide, Ceteareth-20, Squalane, Glycerin, Triethoxycaprylylsilane, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Trisodium Ethylene Disuccinate, Chlorphenesin, Citric Acid, Dimethicone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Oleth-3 Phosphate, PEG-8, Punica Granatum Seed Oil, Avena Sativa (Oat) Peptide, Silica, Camellia Sinensis Leaf Extract, Carbomer, Olea Europaea (Olive) Fruit Extract, Euterpe Oleracea Fruit Extract, Methylisothiazolinone, Tocotrienols, Lauroyl Lysine.

Section 51945-4 (51945-4)



Advanced Anti-Aging Eye Cream Broad Spectrum SPF 37

Wrinkle-reducing oat peptide complex

Supergoop!

Opthamologist tested for sensitive eye area.

0.5 fl. oz./15 ml.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.1% Sunscreen


Advanced Ingredient Data


Raw Label Data

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