FDA Label for Sun Therape Body Spf-35

View Indications, Usage & Precautions

Sun Therape Body 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.........................10.0%

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

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



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), CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TAPIOCA

STARCH, GLYCERYL STEARATE, PEG-100 STEARATE, STEARIC ACID, SIMMONDSIA

CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, CETYL ALCOHOL, PHENOXYETHANOL,

FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, STEARYL ALCOHOL,

PEG-7 GLYCERYL COCOATE, CAPRYLYL GLYCOL, POLYSORBATE 60, SODIUM

HYDROXIDE, ETHYLHEXYLGLCERIN, BHT, HEXYLENE GLYCOL, PANTHENOL, ALOE

BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYLENE GLYCOL, ECHINACEA

ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN

SEAL) EXTRACT, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE,

COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE,

MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL

PHOSPHATE, PERSEA GRATISSIMA (AVOCADO) OIL, ROSA CANINA (ROSE HIP)

FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, GINKGO BILOBA LEAF EXTRACT,

ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, TOCOPHEROL, LIMONIUM GERBERI

EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, CHLORPHENESIN, LECITHIN, PLANKTON

EXTRACT, BENZOIC ACID, SORBIC ACID


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