FDA Label for Sun Therape Pro Sport Spf-35

View Indications, Usage & Precautions

Sun Therape Pro Sport 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



Homosalate..................15%
Octinoxate.....................7.5%
Oxybenzone..................6.0%

Octocrylene................5.5%
Octisalate ...................5.0%
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



• 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 120°F.

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:



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?



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