The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Umbrella Sunscreen (NDC 35192-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, dosage & administration, inactive ingredient, otc - purpose, otc - active ingredient, otc - keep out of reach of children, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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. Protect this product from excessive heat and direct sun
ALOE VERA LEAF, ALUMINUM STARCH OCTENYLSUCCINATE, ASCORBIC ACID, ASCORBYL PALMITATE, BORON NITRIDE, CETOSTEARYL ALCOHOL, CETEARYL ISONONANOATE, CITRIC ACID MONOHYDRATE, CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, ETHYLHEXYLGLYCERIN, GLYCERIN, SUNFLOWER OIL, ISOMALT, LECITHIN SOYBEAN, MACADAMIA OIL, NIACIN, PANTHENOL, PHENOXYETHANOL, LECITHIN SOYBEAN, POTASSIUM SORBATE, PROPANEDIOL, ROSA MOSCHATA OIL, ROSEMARY, SODIUM BENZOATE, HYALURONATE SODIUM, TETRASODIUM IMINODISUCCINATE, TOCOPHEROL, GRAPE SEED OIL, WATER
Sunscreen
Titanium Dioxide, Octinoxate
For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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. Protect this product from excessive heat and direct sun
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