The following Structured Product Label (SPL) was submitted to the FDA by Ca-botana International for the product Sun Defense Cream (NDC 35192-022). 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 warning and precautions section, dosage & administration section, inactive ingredient section, otc - active ingredient section, keep out of reach of children section, 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
CAMELLIA SINENSIS FLOWER
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
STEARYL ALCOHOL
CETYL ALCOHOL
CETEARYL ESONONANOATE
CITRIC ACID MONOHYDRATE
CITRUS AURANTIUM FLOWER OIL
COCO-CAPRYLATE
ETHYLHEXYLGLYCERIN
GLYCERIN
SUNFLOWER OIL
NEACEN
PANTHENOL
PHENOXYETHANOL
EGG PHOSPHOLIPIDS
POTASSIUM SORBATE
PROPANEDIOL
ROSMARINUS OFFICINALIS FLOWERING TOP OIL
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER
SORBITAN STEARATE
TOCOPHEROL
GRAPE SEED OIL
XANTHAN GUM
WATER
OCTINOXATE
TITANIUM DIOXIDE
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.
* Please review the disclaimer below.
