FDA Label for Octinoxate, Octisalate, Avobenzone, Octocrylene, Ensulizole, Titanium Dioxide
View Indications, Usage & Precautions
- 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:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- OHTER INFORMATION:
- CONTENT OF LABELING
Octinoxate, Octisalate, Avobenzone, Octocrylene, Ensulizole, Titanium Dioxide Product Label
The following document was submitted to the FDA by the labeler of this product Prokpil Sas. 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.
Losanika Coffee Bb Cream Broad Spectrum Spf 30 - Avobenzone 2%,Octocrylene 2%,Octinoxate 6%,Ensulizole 2%,Octisalate 4.5%. Titanium Dioxide 2.4% Cream
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.
Purpose:
Sunscreen
Active Ingredients:
AVOBENZONE 2%
OCTOCRYLENE 2%
OCTINOXATE 6%
ENSULIZOLE 2%
OCTISALATE 4.5%
TITANIUM DIOXIDE 2.4%
Uses:
For all sunscreen drug products:
“helps prevent sunburn
Warning:
For external use only
When Using This Product:
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor:
if rash or irritation develops or lasts.
Keep Out Of Reach Of Children:
If the product is swallowed get medical help or contact a poison control center right away.
Directions:
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.
Inactive Ingredients:
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).
Ohter Information:
Protect from excessive heat and direct sunlight.
Formulated with out:
Parabens, silicones, mineral oils, paraffins and synthetic fragrances
* Please review the disclaimer below.