Skin Soothing Mineral Sunscreen Spf 40

Skin Soothing Mineral Sunscreen Spf 40
SPL v6
SPL
SPL Set ID ef24da08-5cb7-4319-aa78-0d9b8636fe67
Route
TOPICAL
Published
Effective Date 2015-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Zinc Cation (10.1 g)
Inactive Ingredients
Water Ethylhexyl Stearate Cyclomethicone 5 Propanediol Butylene Glycol Alkyl (c12-15) Benzoate Potassium Cetyl Phosphate Isohexadecane Cetostearyl Alcohol Dimethicone Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Polyoxyl 20 Cetostearyl Ether Triethoxycaprylylsilane Squalane Xanthan Gum Sunflower Oil Trisodium Ethylenediamine Disuccinate Chlorphenesin Ethylhexylglycerin Oleth-3 Phosphate Pomegranate Seed Oil Safflower Oil Polysorbate 60 Citric Acid Monohydrate Green Tea Leaf Black Olive Acai Methylisothiazolinone Tocotrienols

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-01-22

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 eyes. 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 sunscreen if swimming or sweating

-Children under 6 months: Ask a doctor

-Reapply 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 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

· Use a water resistant sunscreen if swimming or sweating

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

Inactive ingredients Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Triethoxycaprylylsilane, Squalane, Xanthan Gum, Helianthus Annuus (sunflower) Seed Oil, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Ethylhexylglycerin, Oleth-3 Phosphate, Punica Granatum Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Citric Acid, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Fruit extract, Euterpe Oleracaea Fruit Extract, Methylisothiazolinone, Tocotrienols

Section 51945-4

Supergoop Skin Soothing Mineral Sunscreen

with Olive Polyphenols

Broad Spectrum SPF 40

2.4 fl. oz./ 71 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 sunscreen if swimming or sweating

-Children under 6 months: Ask a doctor

-Reapply 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 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

· Use a water resistant sunscreen if swimming or sweating

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 eyes. 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)

Inactive ingredients Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Triethoxycaprylylsilane, Squalane, Xanthan Gum, Helianthus Annuus (sunflower) Seed Oil, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Ethylhexylglycerin, Oleth-3 Phosphate, Punica Granatum Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Citric Acid, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Fruit extract, Euterpe Oleracaea Fruit Extract, Methylisothiazolinone, Tocotrienols

Section 51945-4 (51945-4)

Supergoop Skin Soothing Mineral Sunscreen

with Olive Polyphenols

Broad Spectrum SPF 40

2.4 fl. oz./ 71 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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