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.

Active Ingredient

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.1% Sunscreen

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


Structured Label Content

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.

Active Ingredient (55106-9)

Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Zinc Oxide 10.1% Sunscreen

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

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


Advanced Ingredient Data


Raw Label Data

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