OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE- octisalate,octocrylene,octinoxate,zinc oxide,titanium dioxide,ensulizole 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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ALOE & CALENDUAL ANTIOXIDENT SUNSCREEN BROAD SPECTRUM SPF30

LOSANIKA ALOE & CALENDULA ANTIOXIDANT SUNSCREEN BROAD SPECTRUM SPF 30 - ENSULIZOLE 2.0 %, TITANIUM DIOXIDE 2.4 %, OCTOCRYLENE 3.0 %, ZINC OXIDE 3.5 %, OCTISALATE 4.5 %, OCTINOXATE 6.5 %

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with

regulations and policies. FDA has not evaluated weather this product complies.

PURPOSE:

SUNSCREEN

DRUG FACTS:

ACTIVE INGREDIENTS:

ENSULIZOLE 2.0 %

TITANIUM DIOXIDE 2.4 %

OCTOCRYLENE 3.0 %

ZINC OXIDE 3.5 %

OCTISALATE 4.5 %

OCTINOXATE 6.5 %

USES:

the risk of skin cancer and early skin aging caused by the sun.

WARNING:

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 or irritation develops or lasts.

KEEP OUT OF REACH OF CHILDREN:

If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS:

Apply liberally 15 minutes before sun exposure

Use water resistant sun protector if swimming or sweating.
Reapply at least every two hours.
Children under six months: ask a doctor

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.

INACTIVE INGREDIENTS:

Water (Aqua), Aloe vera (Aloe) Leaf juice, Calendula officinalis (calendula) flower extract, Aluminum Starch Octenylsuccinate,C12-15 Alkyl Benzoate, Propylheptyl Caprylate, Dicaprylyl Carbonate (and) Stearalkonium Hectorite (and) Propylene Carbonate, Cetearyl Alcohol, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Coffea arabica (Coffee) seed oil, Sodium Stearoyl Glutamate, Tocopheryl Acetate(E), Niacinamide (B3), Panthenol, Glycerin, Xanthan Gum, Fragrance, Phenoxyethanol (And) Decylene Glycol (And) Caprylyl Glycol, Bixa Orellana Seed Extract (Annato), Cymbopogon citratus (lemongrass) oil, Zingiber officinale (ginger) root oil, Citrus sinensis (sweet orange) peel oil, Lippia alba (bushy matgrass) leaf/stem oil.

OTHER INFORMATION:

Protect from excessive heat and direct sunlight.

Formulated without: parabens, silicones, mineral oils, synthetic dyes.

CONTENT OF LABELING:

CONTENT OF LABELING

OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE 
octisalate,octocrylene,octinoxate,zinc oxide,titanium dioxide,ensulizole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71801-542
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BIXA ORELLANA SEED (UNII: O87354RZ5A)  
NIACINAMIDE (UNII: 25X51I8RD4)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DECYLENE GLYCOL (UNII: S57M60MI88)  
GINGER OIL (UNII: SAS9Z1SVUK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LIPPIA ALBA WHOLE (UNII: 76HT054LK1)  
ORANGE OIL (UNII: AKN3KSD11B)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71801-542-01 30 g in 1 BOX; Type 0: Not a Combination Product 06/18/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018
Labeler - PROKPIL SAS (886026583)

Revised: 6/2018
Document Id: 6eafbc1c-44d9-5837-e053-2a91aa0ad979
Set id: 6eafbc1c-44d8-5837-e053-2a91aa0ad979
Version: 1
Effective Time: 20180618
 
PROKPIL SAS