Pharmagel - Sun Therape Sport Spray (67879-304)

Pharmagel - Sun Therape Sport Spray (67879-304)
SPL v8
SPL
SPL Set ID 0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d9
Route
TOPICAL
Published
Effective Date 2015-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (6 g) Octocrylene (5.5 g) Octisalate (5 g) Avobenzone (3 g) Homosalate (15 g) Octinoxate (7.5 g)
Inactive Ingredients
Echinacea Angustifolia Hydrastis Canadensis Whole Limonium Gerberi Whole Lecithin, Soybean Chondrus Crispus Anhydrous Citric Acid Sodium Benzoate Alcohol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Octyl Acrylate Diethylene Glycol Monoethyl Ether Coconut Oil Butylene Glycol Trisiloxane .alpha.-tocopherol Acetate Dimethicone Polyester-10 Propylene Glycol Dibenzoate Gardenia Taitensis Flower Borago Officinalis Seed Butyloctyl Salicylate Macadamia Oil Panthenol Avocado Oil Tetrahexyldecyl Ascorbate Water Simmondsia Chinensis Seed Aloe Vera Leaf Phenoxyethanol Deanol Bitartrate Rosa Canina Fruit Medium-chain Triglycerides Chlorphenesin Benzoic Acid Sorbic Acid Achillea Millefolium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-18

Description

Homosalate..................15% Octinoxate.....................7.5% Oxybenzone..................6.0% Octocrylene................5.5% Octisalate ...................5.0% Avobenzone................3.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Homosalate..................15% Octinoxate.....................7.5% Oxybenzone..................6.0% Octocrylene................5.5% Octisalate ...................5.0% Avobenzone................3.0%

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Section 60561-8

• Flammable: Keep away from flame or high heat. Avoid spraying in eyes. Contents under pressure. DO not puncture or incinerate. DO not store at temperature above 120ºF.

Other Information

• Protect the product in this container from excessive heat

and direct sun

Warnings

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

• Stop use and ask doctor if rash occurs

Active Ingredients

Homosalate..................15%

Octinoxate.....................7.5%

Oxybenzone..................6.0%

Octocrylene................5.5%

Octisalate ...................5.0%

Avobenzone................3.0%

Inactive Ingredients:

ALCOHOL DENAT, POLYESTER-8, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ETHOXYDIGLYCOL, COCOS NUCIFERA (COCONUT) OIL, BUTYLENE GLYCOL, TRISILOXANE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE, DIMETHICONE, POLYESTER-10, PROPYLENE GLYCOL DIBENZOATE, GARDENIA TAHITENSIS (TIARE) FLOWER, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DIMETHYLAMINOETHANOL TARTRATE, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHLORPHENESIN, BENZOIC ACID, SORBIC ACID, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, LIMONIUM GERBERI EXTRACT, LECITHIN PLANKTON EXTRACT, CITRIC ACID, SODIUM BENZOATE

Questions Or Comments?

Call toll free 800-882-4889

Directions for Sunscreen Use:

• Apply liberally and evenly 15 minutes before sun exposure

• 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

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months: Ask a doctor


Structured Label Content

Uses (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 (50565-1)

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

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

• Flammable: Keep away from flame or high heat. Avoid spraying in eyes. Contents under pressure. DO not puncture or incinerate. DO not store at temperature above 120ºF.

Other Information

• Protect the product in this container from excessive heat

and direct sun

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

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

• Stop use and ask doctor if rash occurs

Active Ingredients (ACTIVE INGREDIENTS)

Homosalate..................15%

Octinoxate.....................7.5%

Oxybenzone..................6.0%

Octocrylene................5.5%

Octisalate ...................5.0%

Avobenzone................3.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

ALCOHOL DENAT, POLYESTER-8, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ETHOXYDIGLYCOL, COCOS NUCIFERA (COCONUT) OIL, BUTYLENE GLYCOL, TRISILOXANE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE, DIMETHICONE, POLYESTER-10, PROPYLENE GLYCOL DIBENZOATE, GARDENIA TAHITENSIS (TIARE) FLOWER, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DIMETHYLAMINOETHANOL TARTRATE, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHLORPHENESIN, BENZOIC ACID, SORBIC ACID, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, LIMONIUM GERBERI EXTRACT, LECITHIN PLANKTON EXTRACT, CITRIC ACID, SODIUM BENZOATE

Questions Or Comments? (Questions or Comments?)

Call toll free 800-882-4889

Directions for Sunscreen Use: (Directions For Sunscreen Use:)

• Apply liberally and evenly 15 minutes before sun exposure

• 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

• Reapply at least every 2 hours

• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months: Ask a doctor


Advanced Ingredient Data


Raw Label Data

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