FDA Label for Sun Therape Face Spf-35

View Indications, Usage & Precautions

Sun Therape Face Spf-35 Product Label

The following document was submitted to the FDA by the labeler of this product Pharmagel International Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



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

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

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

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


Purpose



SUNSCREEN


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



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


Otc - Keep Out Of Reach Of Children



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


Other Safety Information



Other Information
• Protect the product in this container from excessive heat and direct sun


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


Inactive Ingredients:



WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, GLYCERYL STEARATE, PEG-100

STEARATE, CETEARYL ALCOHOL, STEARIC ACID, DIMETHICONE, FRAGRANCE (PARFUM),

PHENOXYETHANOL, 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, 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, ROSA CANINA

(ROSE HIP) FRUIT EXTRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE,

UNDECYLENOYL PHENYLALANINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCYRRHIZA GLABRA

(LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CYPERUS ROTUNDUS

ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA)

EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED

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


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