DAILY DEFENSE SPF 30 OIL FREE FLUID- ensulizole, octinoxate and titanium dioxide cream 
Natura Bisse International, S.A.

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.

----------

Daily Defense

anti-aging protective sunscreen

Active Ingredients: ENSULIZOLE (PHENYLBENZIMIDAZOLE SULFONIC ACID) 3%
OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 7.5%
TITANIUM DIOXIDE 6.3%

Other Ingredients: WATER, COCOGLYCERIDES, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, DISTARCH PHOSPHATE, TRIETHANOLAMINE, GLYCERIN, GLYCERYL STEARATE, CETYL ALCOHOL, ALUMINA, BEESWAX, AMARANTHUS CAUDATUS SEED EXTRACT, HYDROLYZED COLLAGEN, ETHYLHEXYLGLYCERIN, DIMETHICONE, SODIUM POLYACRYLATE, STEARALKONIUM HECTORITE, PEG-75 STEARATE, POLYURETHANE-39, TOCOPHERYL ACETATE, GLYCERYL LINOLEATE, DISABOLOL, PENTYLENE GLYCOL, UREA, LACTIC ACID, SODIUM LACTATE, SERINE, SORBITOL, ACRYLAMIDE/AMMONIU ACRYLATE COPOLYMER, SILICA, CETETH-20, STEARETH-20, PROPYLENE CARBONATE, POLYSOBUTENE, SODIUM CITRATE, POLYSORBATE 20, GLYCERYL, DISODIUM EDTA, BUTYLENE GLYCOL, TOCOPHEROL, ALLANTOIN, SODIUM CHLORIDE, DEHYDROACETIC ACID, BENZOIC ACID, PHENOXYETHANOL, FRAGRANCE.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

not tested on animals

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. High sun protection product. Do not use this product if the seal is broken.

Natura Bisse Barcelona
NB Ceutical
SPF 30
Daily Defense
Oil Free Fluid
Anti aging protective sunscreen
NET WT. 2.5 OZ
e 75 ml.
Natura Bisse barcelona
SPF 30 Daily Defense Oil Free Fluid
Anti aging protective sunscreen
Paraben free
Allergy Tested
UVA in accordance with the European Commission Recommendation
Made in Spain by Natura Bisse INT. S.A.
Cerdanyola 08290 Barcelona
Not tested on animals
Natura Bisse INT. S.A. Barcelona, Espana
Herschel No 50 Colonia Anzures. Delegacion Miguel Hidalgo C.P. 11590 Mexico, D.F. RFC NBI10402132PO

image description

DAILY DEFENSE  SPF 30 OIL FREE FLUID
ensulizole, octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-221
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole5.52 g  in 75 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.23 g  in 75 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide5.29 g  in 75 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
Trolamine (UNII: 9O3K93S3TK)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Aluminum Oxide (UNII: LMI26O6933)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Dimethicone (UNII: 92RU3N3Y1O)  
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
Glyceryl Linolenate (UNII: SGB6X4G86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Pentylene Glycol (UNII: 50C1307PZG)  
Urea (UNII: 8W8T17847W)  
Lactic Acid (UNII: 33X04XA5AT)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Serine (UNII: 452VLY9402)  
Sorbitol (UNII: 506T60A25R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Ceteth-20 (UNII: I835H2IHHX)  
Steareth-20 (UNII: L0Q8IK9E08)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Edetate Disodium (UNII: 7FLD91C86K)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Allantoin (UNII: 344S277G0Z)  
Sodium Chloride (UNII: 451W47IQ8X)  
Dehydroacetic Acid (UNII: 2KAG279R6R)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63730-221-0175 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:63730-221-022 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:63730-221-0310 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/19/201001/18/2016
Labeler - Natura Bisse International, S.A. (464431576)
Registrant - Natura Bisse International, S.A. (464431576)
Establishment
NameAddressID/FEIBusiness Operations
Natura Bisse International, S.A.464431576manufacture(63730-221)

Revised: 1/2016
 
Natura Bisse International, S.A.