OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE- octinoxate,octisalate,avobenzone,octocrylene,ensulizole,titanium dioxide cream 
PROKPIL SAS

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.

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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

DRUG FACTS:

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

CONTENT OF LABELING

CONTENT OF LABELING

OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE 
octinoxate,octisalate,avobenzone,octocrylene,ensulizole,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71801-541
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
LIPPIA ALBA WHOLE (UNII: 76HT054LK1)  
MANDARIN OIL (UNII: NJO720F72R)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71801-541-0130 g in 1 BOX; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2017
Labeler - PROKPIL SAS (886026583)

Revised: 2/2021
Document Id: ba61353d-f750-704e-e053-2995a90abbf2
Set id: 5c4230af-280e-2b73-e053-2991aa0aa4a9
Version: 5
Effective Time: 20210202
 
PROKPIL SAS