Soleil Spf-15

Soleil Spf-15
SPL v1
SPL
SPL Set ID 33e4bbda-0f86-4b42-b7bd-5317ef86d36c
Route
TOPICAL
Published
Effective Date 2015-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5 mg) Octisalate (3 mg) Zinc Cation (2.5 mg)
Inactive Ingredients
Methacrylate/methoxy Peg-10 Maleate/styrene Copolymer Fucus Vesiculosus Aloe Vera Leaf Water Artemisia Pallens Whole Levomenol Green Tea Leaf Caprylic/capric/linoleic Triglyceride Cetyl Alcohol Cetearyl Olivate Citrus Aurantium Flower Oil Citrus Aurantium Fruit Citrus Limon Fruit Oil Citrus Nobilis Citrus Sinensis Fruit Oil Carrot Ethyl Acetoacetate Eucalyptus Globulus Whole Gluconolactone Glycerin Sunflower Oil Piperonal Isoamyl Acetate Isobutyl Acetate Jasminum Sambac Whole Lecithin, Soybean Opopanax Chironium Whole Polysorbate 20 Peg/ppg-17/6 Copolymer Salvia Sclarea Seed Oil Sodium Benzoate Sorbitan Olivate Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-02-13

Description

For external use only. Flammable: Do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center immediately.


Medication Information

Warnings and Precautions

For external use only. Flammable: Do not use

near heat, flame, or while smoking. Do not use on damaged

or broken skin. When using this product keep out of eyes.

Rinse with water to remove. Stop use and ask a doctor if rash

occurs. Keep out of reach of children. If the product is

swallowed, get medical help or contact a Poison Control

Center immediately.

Description

For external use only. Flammable: Do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center immediately.

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 50565-1

Keep out of reach of children

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octinoxate 5.0%, Octisalate

3.0%, Zinc Oxide 2.5%

Directions

Apply liberally 20 minutes prior to sun

exposure. Do not spray onto face. Spray into hands and apply

to face. Use in well-ventilated areas. Reapply: immediately

after swimming, sweating or towel drying and 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 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.

Other Information

May stain or damage some fabrics or

surfaces. Avoid long term storage above 40°C (120°F).

Protect this product from excessive heat and direct sun.


Structured Label Content

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.

Warnings and Precautions (34071-1)

For external use only. Flammable: Do not use

near heat, flame, or while smoking. Do not use on damaged

or broken skin. When using this product keep out of eyes.

Rinse with water to remove. Stop use and ask a doctor if rash

occurs. Keep out of reach of children. If the product is

swallowed, get medical help or contact a Poison Control

Center immediately.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octinoxate 5.0%, Octisalate

3.0%, Zinc Oxide 2.5%

Directions

Apply liberally 20 minutes prior to sun

exposure. Do not spray onto face. Spray into hands and apply

to face. Use in well-ventilated areas. Reapply: immediately

after swimming, sweating or towel drying and 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 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.

Other Information (Other information)

May stain or damage some fabrics or

surfaces. Avoid long term storage above 40°C (120°F).

Protect this product from excessive heat and direct sun.


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Raw Label Data

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