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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