Pharmagel - Sun Therape Face And Body (67879-309)

Pharmagel - Sun Therape Face And Body (67879-309)
SPL v8
SPL
SPL Set ID 6a96623f-c37c-4e67-925e-f133461d726d
Route
TOPICAL
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Oxybenzone (3 g) Avobenzone
Inactive Ingredients
Water Ethylhexyl Palmitate Propylene Glycol Glyceryl Monostearate Peg-100 Stearate Cetostearyl Alcohol Dimethicone Palmitic Acid Medium-chain Triglycerides Phenoxyethanol Stearic Acid Myristyl Myristate Caprylyl Glycol Hydroxyethyl Cellulose (2000 Cps At 1%) Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Ethylhexylglycerin Allantoin Hexylene Glycol Myristyl Laurate Panthenol Edetate Sodium Aminomethylpropanol Glycerin Glycolic Acid Butylene Glycol Morus Alba Leaf Tea Leaf Cardamom Jasminum Officinale Flower Rosa Centifolia Flower Myristic Acid Borage Oil Butyloctyl Salicylate Coconut Oil Deanol Bitartrate Kojic Acid Macadamia Oil Magnesium Ascorbyl Phosphate Niacin Avocado Oil Phyllanthus Emblica Fruit .alpha.-tocopherol Acetate Aloe Vera Leaf Undecylenoyl Phenylalanine Glycyrrhiza Glabra Arachidic Acid Green Tea Leaf Butylated Hydroxytoluene Balsam Fir Leafy Twig Cananga Odorata Flower Arabica Coffee Bean Cantaloupe Galbanum Hyacinthus Orientalis Flower Apple Cyperus Rotundus Root Achillea Millefolium Echinacea Angustifolia Goldenseal Simmondsia Chinensis Seed Rosa Canina Fruit Ginkgo Limonium Gerberi Flowering Top Sodium Benzoate Lactic Acid Undecylenic Acid Potassium Sorbate Fd&c Yellow No. 6 Lecithin, Soybean Phymatolithon Calcareum Chlorphenesin Fd&c Red No. 40 Benzoic Acid Sorbic Acid

Identifiers & Packaging

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

Description

Avobenzone..........................3.0% Octinoxate............................7.5% Octisalate.............................5.0% Oxybenzone..........................3.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Avobenzone..........................3.0% Octinoxate............................7.5% Octisalate.............................5.0% Oxybenzone..........................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

Warnings

• For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with warm water to remove

• Stop use and ask doctor if rash occurs

Other Information
  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
Active Ingredients

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

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

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

Oxybenzone..........................3.0%

Inactive Ingredients:

WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, DIMETHICONE, PALMITIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, STEARIC ACID, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN, GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, CAMELLIA SINENSIS (BLACK TEA) LEAF EXTRACT, ELETTARIA CARDAMOMUM SEED EXTRACT, JASMINUM OFFICINALE FLOWER/LEAF EXTRACT, ROSE EXTRACT, MYRISTIC ACID, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE, NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARACHIDIC ACID, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, BHT, ABIES BALSAMEA (BALSAM CANADA) EXTRACT, CANANGA ODORATA (YLANG) FLOWER EXTRACT, COFFEA ARABICA LEAF/SEED EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, FERULA GALBANIFLUA GUM EXTRACT, HYACINTHUS ORIENTALUS (HYACINTHUS) FLOWER EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID, UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT, CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

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)

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

• For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with warm water to remove

• Stop use and ask doctor if rash occurs

Other Information (OTHER INFORMATION)
  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
Active Ingredients (ACTIVE INGREDIENTS)

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

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

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

Oxybenzone..........................3.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, DIMETHICONE, PALMITIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, STEARIC ACID, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN, GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, CAMELLIA SINENSIS (BLACK TEA) LEAF EXTRACT, ELETTARIA CARDAMOMUM SEED EXTRACT, JASMINUM OFFICINALE FLOWER/LEAF EXTRACT, ROSE EXTRACT, MYRISTIC ACID, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE, NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARACHIDIC ACID, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, BHT, ABIES BALSAMEA (BALSAM CANADA) EXTRACT, CANANGA ODORATA (YLANG) FLOWER EXTRACT, COFFEA ARABICA LEAF/SEED EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, FERULA GALBANIFLUA GUM EXTRACT, HYACINTHUS ORIENTALUS (HYACINTHUS) FLOWER EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID, UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT, CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

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

All Sections (JSON)