The following Structured Product Label (SPL) was submitted to the FDA by Prokpil Sas for the product Octinoxate, Octisalate, Avobenzone, Octocrylene, Ensulizole, Titanium Dioxide (NDC 71801-541). 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 losanika coffee bb cream broad spectrum spf 30 - avobenzone 2%,octocrylene 2%,octinoxate 6%,ensulizole 2%,octisalate 4.5%. titanium dioxide 2.4% cream, purpose:, active ingredients:, uses:, warning:, when using this product:, stop use and ask a doctor:, keep out of reach of children:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Sunscreen
AVOBENZONE 2%
OCTOCRYLENE 2%
OCTINOXATE 6%
ENSULIZOLE 2%
OCTISALATE 4.5%
TITANIUM DIOXIDE 2.4%
For all sunscreen drug products:
“helps prevent sunburn
For external use only
keep out of eyes. Rinse with water to remove.
if rash or irritation develops or lasts.
If the product is swallowed get medical help or contact a poison control center right away.
Apply generously and evenly 15 minutes before sun exposure
Reapply at least every two hours
Use water resistant sun protector if swimming or sweating.
Sun protection measures:
Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging.
To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures.
Limit exposure time especially between 10 am - 2 pm.
Wear long sleeves, hat and glasses.
Children under 6 months of age ask a doctor.
Water/Aqua, Aloe Barbadensis Leaf Water, Coffea Arabica Seed Extract, Coffea Arabica Seed Oil, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, Butyl Methoxydibenzoylmethane, Phenylbenzimidazole Sulfonic Acid, Octocrylene, Propylheptyl Caprylate,Titanium Dioxide, Calendula officinalis flower extract, Cetearyl Alcohol, Dicaprylyl Carbonate(and)Stearalkonium Hectorite (and) Propylene Carbonate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Panthenol,Sodium Polyacrylate, Phenoxyethanol and Caprylyl Glycol, Xanthan Gum, Polyamide – 3, Cymbopongo citratus leaf oil , Lippia Alba Leaf/Stem Oil, Citrus nobilis (mandarin orange) peel oil, CI 77891 (Titanium dioxide), CI 77491 (Iron oxide red), CI 77492 (Iron oxide yellow), CI 77499 (Iron oxide Black).
Protect from excessive heat and direct sunlight.
Formulated with out:
Parabens, silicones, mineral oils, paraffins and synthetic fragrances
* Please review the disclaimer below.
